Selected Vegetables/Sun’s Soup (PDQ

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Selected Vegetables/Sun’s Soup (PDQ®)     
Last Modified: 06/22/2004
Health Professional Version

Table of Contents

Overview
General Information
History
Laboratory/Animal/Preclinical Studies
Human/Clinical Studies
Adverse Effects
Level of Evidence for Selected Vegetables/Sun’s Soup
Changes to This Summary (06/22/2004)
More Information

Overview

This complementary and alternative medicine (CAM) information summary provides an overview of the use of Selected Vegetables/Suns Soup as an anticancer treatment. The summary includes a brief history of Selected Vegetables/Suns Soup and a review of animal and human studies. Much of the information in the Human/Clinical Studies section is summarized in a table located at the end of that section.

This summary contains the following key information:

- Selected Vegetablesand Suns Soupare names given to several different mixtures of vegetables and herbs that have been studied as treatments for cancer. These mixtures were developed by a single individual.

- At present, 2 formulations of Selected Vegetables/Suns Soup are marketed in the United States as dietary supplements.

- The vegetables and herbs in Selected Vegetables/Suns Soup are thought to have anticancer and/or immune-systemstimulating properties.

- It has been reported that treatment with Selected Vegetables/Suns Soup lengthened the survival of patients with advanced non-small cell lung cancer or other types of malignant tumors. However, different formulations of Selected Vegetables/Suns Soup were used in the studies reported to date, making the comparison of results across studies difficult, and design weaknesses in the studies raise doubts about the reliability of the findings.

- Additional clinical studies of Selected Vegetables/Suns Soup are being conducted or contemplated.
Many of the medical and scientific terms used in the summary are hypertext linked (at first use in each section) to the Cancer.gov Dictionary 1, which is oriented toward nonexperts. When a linked term is clicked, a definition will appear in a separate window. All linked terms and their corresponding definitions will appear in a glossary in the printable version of the summary.

Reference citations in some PDQ CAM information summaries may include links to external Web sites that are operated by individuals or organizations for the purpose of marketing or advocating the use of specific treatments or products. These reference citations are included for informational purposes only. Their inclusion should not be viewed as an endorsement of the content of the Web sites, or of any treatment or product, by the PDQ Cancer CAM Editorial Board or the National Cancer Institute (NCI).

General Information

Selected Vegetablesand Suns Soupare names given to several different mixtures of vegetables and herbs that have been studied as treatments for cancer and other medical conditions, including acquired immunodeficiency syndrome (AIDS).[1-6] The original formulation contained Lentinus edodes (shiitake mushroom), mung bean, Hedyotis diffusa (also known by the Chinese herbal name Bai Hua She She Cao), and Scutellaria barbata (barbat skullcap; also known by the Chinese herbal name Ban Zhi Lian).[1]

A second formulation, specifically named Selected Vegetables(or SV), was tested in a phase I/II clinical trial that involved patients with advanced non-small cell lung cancer (see Human/Clinical Studies).[4] SV, which is a freeze-dried vegetable and herb product, is marketed in the United States as a dietary supplement under the names Freeze-dried SVor DSV.[5]

A third formulation, called Frozen SVor FSV,has also been studied clinically in patients with advanced non-small cell lung cancer (see Human/Clinical Studies).[6] FSV, like SV/DSV, is marketed in the United States as a dietary supplement.[5]

In the United States, dietary supplements are regulated as foods, not drugs. Therefore, premarket evaluation and approval by the Food and Drug Administration (FDA) are not required unless specific disease prevention or treatment claims are made. The FDA can, however, remove from the market dietary supplements that it deems unsafe. It should be noted that no formulation of Selected Vegetables/Suns Soup has been approved by the FDA for the treatment of cancer or any other medical condition.

Because dietary supplements are not formally reviewed for manufacturing consistency, there may be considerable variation from lot to lot, and there is no guarantee that ingredients identified on product labels are present in the specified amounts or present at all.

SV/DSV and FSV are reported to contain soybean, shiitake mushroom, mung bean, red date, scallion, garlic, leek, lentil, Hawthorn fruit, onion, ginseng, Angelica root, licorice, dandelion root, senega root, ginger, olive, sesame seed, and parsley.[4,6]

Many of the ingredients in Selected Vegetables/Suns Soup were chosen because previous biochemical research and traditional Chinese medicine suggested they contain molecules that have anticancer or immune-systemstimulating activity. Reviewed in [1-6]

Selected Vegetables/Suns Soup is administered orally, as part of the diet.[1,4,6] Reviewed in [3] Studies in humans have not always specified a dose or an administration schedule (e.g., [1] ), but daily doses either of 30 g SV/DSV, mixed with water or other soup, or of 10 oz (approximately 283 g) FSV were used in the above-mentioned clinical studies in patients with advanced non-small cell lung cancer.[4,6]

To conduct clinical drug research in the United States, researchers must file an Investigational New Drug (IND) application with the FDA. An IND must also be obtained for clinical evaluation of dietary supplements as agents for the treatment or prevention of disease. Because the IND application process is confidential and because the existence of an IND can be disclosed only by the applicants, it is not known whether an IND currently exists for the study of Selected Vegetables/Suns Soup as a treatment for cancer or any other disease.

In this summary, the specific formulation of Selected Vegetables/Suns Soup given to individual patients or groups of patients will be identified wherever possible.

References

1. Sun AS: Herbal Treatment of Malignancy. US Patent 5437866. August 1, 1995. Washington, DC: US Patent and Trademark Office, 1995. Available online. 2 Last accessed June 21, 2004. 
2. Sun A: Food therapy for non-small cell lung cancer. In: Comprehensive Cancer Care: Integrating Complementary and Alternative Therapies – A Conference for Health professionals, June 12-14, 1998. Breakout Session 405: Herbal Therapies. Available online. 3 Last accessed June 21, 2004. 
3. Cancer Advisory Panel for Complementary and Alternative Medicine (CAPCAM).: Minutes of the First Meeting – July 8-9, 1999: Section X: Phase I/II study of stage III and IV non-small cell lung cancer patients taking a specific dietary supplement – Dr. Alexander Sun, Medical Director, Connecticut Institute of Aging and Cancer. Bethesda, Md: National Center for Complementary and Alternative Medicine, 2002. Available online. 4 Last accessed June 21, 2004. 

History

Selected Vegetables/Suns Soup was first conceived as a treatment for cancer in the mid-1980s. In an effort to help a relative who was diagnosed with stage IV non-small cell lung cancer (metastasis to the left adrenal gland), the developer created a mixture that contained shiitake mushroom, mung bean, Hedyotis diffusa, and Scutellaria barbata in the belief that these plant materials had anticancer and/or immune-systemstimulating properties.[1-3] After the relative appeared to benefit from this treatment (the relative was reported to be alive and cancer free more than 13 years later [3] ), 3 additional patients (1 with stage IV kidney cancer that had metastasized to the lungs, 1 with stage IV kidney cancer that had metastasized to the liver and to the lungs, and 1 with stage IV non-small cell lung cancer that had metastasized to the brain) were treated with a variant of the original mixture, i.e., a combination of shiitake mushroom and mung bean.[1] (Note: No explanation has been given for the omission of Hedyotis diffusa and Scutellaria barbata for these patients.) These additional patients were also said to benefit from vegetable/herb treatment.[1] (See Human/Clinical Studies.)

In June 1992, the developer filed a patent application for the Herbal treatment of malignancy,and a patent was awarded in August 1995.[1] Also in June 1992, the developer initiated a clinical trial in the Czech Republic to test Selected Vegetables/Suns Soup as a treatment for advanced non-small cell lung cancer.[4] A second clinical study (a nonconsecutive case series) that also involved patients with advanced non-small cell lung cancer was completed in 1997.[5] It is unclear, however, when patient accrual for this second study began.[5] In both reports of the clinical study results, the authors concluded that patients who received Selected Vegetables/Suns Soup had prolonged survival.[4,5] (See Human/Clinical Studies.)

In 1998, the developer reported at a scientific conference that additional patients with various other types of cancer had benefited from treatment with Selected Vegetables/Suns Soup.[2] (See Human/Clinical Studies.)

As noted previously (General Information), the proposed mechanism of action for Selected Vegetables/Suns Soup involves anticancer and/or immune-systemstimulating activities associated with some of the ingredients. Reviewed in [1-5] The following types of compounds likely found in Selected Vegetables/Suns Soup have been investigated for these activities: protease inhibitors and autoclave-resistant factor, which are found in soybeans; plant sterols; saponin; inositol hexaphosphate (IP6); beta-glucans; lectins; coumestans such as coumestrol; and isoflavones such as daidzein, genistein, and biochanin A. Reviewed in [4,5]

One beta-glucan found in shiitake mushroom, i.e., lentinan, has been used as an adjunctive therapy for cancer (primarily gastric cancer and colorectal cancer) in Japan.[6,7] Reviewed in [8,9] Treatment with lentinan has been reported to prolong the survival of patients with gastric cancer [6,7] Reviewed in [8,9] and to improve their quality of life.[6] However, lentinan may not be an active component in Selected Vegetables/Suns Soup. This compound has a large molecular mass and is believed to have only limited oral bioavailability. Reviewed in [8-10] Therefore, lentinan has usually been given by intravenous injection. Nonetheless, other substances in shiitake mushroom have been identified as having greater oral bioavailability, and these substances have shown anticancer activity in animal experiments. Reviewed in [8,10]

References

1. Sun AS: Herbal Treatment of Malignancy. US Patent 5437866. August 1, 1995. Washington, DC: US Patent and Trademark Office, 1995. Available online. 2 Last accessed June 21, 2004. 
2. Sun A: Food therapy for non-small cell lung cancer. In: Comprehensive Cancer Care: Integrating Complementary and Alternative Therapies – A Conference for Health professionals, June 12-14, 1998. Breakout Session 405: Herbal Therapies. Available online. 3 Last accessed June 21, 2004. 
3. Cancer Advisory Panel for Complementary and Alternative Medicine (CAPCAM).: Minutes of the First Meeting – July 8-9, 1999: Section X: Phase I/II study of stage III and IV non-small cell lung cancer patients taking a specific dietary supplement – Dr. Alexander Sun, Medical Director, Connecticut Institute of Aging and Cancer. Bethesda, Md: National Center for Complementary and Alternative Medicine, 2002. Available online. 4 Last accessed June 21, 2004. 
4. Sun AS, Ostadal O, Ryznar V, et al.: Phase I/II study of stage III and IV non-small cell lung cancer patients taking a specific dietary supplement. Nutr Cancer 34 (1): 62-9, 1999.  [PUBMED Abstract]
5. Sun AS, Yeh HC, Wang LH, et al.: Pilot study of a specific dietary supplement in tumor-bearing mice and in stage IIIB and IV non-small cell lung cancer patients. Nutr Cancer 39 (1): 85-95, 2001.  [PUBMED Abstract]
6. Nakano H, Namatame K, Nemoto H, et al.: A multi-institutional prospective study of lentinan in advanced gastric cancer patients with unresectable and recurrent diseases: effect on prolongation of survival and improvement of quality of life. Kanagawa Lentinan Research Group. Hepatogastroenterology 46 (28): 2662-8, 1999 Jul-Aug.  [PUBMED Abstract]

Laboratory/Animal/Preclinical Studies

Only limited information is available from laboratory or animal studies of Selected Vegetables/Suns Soup. The developers patent document describes 4 animal experiments that used 2 mouse tumor models (mouse sarcoma S1509a, which was used in 3 of the experiments, and mouse Line 1 lung carcinoma, which was used in 1 experiment) and that evaluated shiitake mushroom, mung bean, Hedyotis diffusa, and Scutellaria barbata.[1]

In these experiments, small groups of mice were fed either standard laboratory chow or laboratory chow that had been mixed with 1 or more of the 4 named substances. The mice were fed these diets both before and after they received subcutaneous injections of tumor cells. Results presented in the patent document show that tumor growth was slower in mice fed the experimental diets (i.e., containing the substances) than in mice fed standard laboratory chow. However, the greatest inhibition of tumor growth (up to 85% inhibition) was observed in animals fed diets that contained both mung bean and shiitake mushroom.

Results of 2 additional animal experiments were reported by the developer in a peer-reviewed scientific journal.[2] One experiment was a repetition of the Line 1 lung carcinoma experiment that was described in the developers patent document. The results of this experiment were similar to those obtained previously: tumor growth was slower in animals fed the experimental diets, with the greatest inhibition of tumor growth (up to 82% inhibition) observed in animals fed a diet that contained both mung bean and shiitake mushroom.

The second experiment also used the Line 1 lung carcinoma tumor model. In this experiment, tumor growth was measured in mice fed either standard laboratory chow or a mixture of standard laboratory chow and DSV (i.e., the commercially available freeze-dried formulation of Selected Vegetables/Suns Soup; see General Information). Tumor growth was approximately 2.3 times slower (i.e., approximately 65% growth inhibition) in mice fed standard laboratory chow plus DSV than in mice fed standard laboratory chow alone.

References

1. Sun AS: Herbal Treatment of Malignancy. US Patent 5437866. August 1, 1995. Washington, DC: US Patent and Trademark Office, 1995. Available online. 2 Last accessed June 21, 2004. 

Human/Clinical Studies

The following information is summarized in a table located at the end of this section.

The use of Selected Vegetables/Suns Soup as a treatment for human cancer has been investigated in only a limited manner. All available resourcesthe developers patent document,[1] the transcript of a presentation made at a scientific conference,[2] the transcript of a meeting of the Cancer Advisory Panel on Complementary and Alternative Medicine (CAPCAM; a joint advisory panel formed by the National Cancer Institute and the National Center for Complementary and Alternative Medicine),[3] and the published reports of 2 clinical studies [4,5] have identified fewer than 50 treated patients.

As noted previously (History), the developers patent document describes 4 patients with advanced cancer who reportedly benefited from treatment with Selected Vegetables/Suns Soup.[1] Among the 4, 3 patients were said to have had complete tumor regression. However, 2 of the 4 patients were treated concurrently with chemotherapy and radiation therapy, and the remaining 2 were treated with concurrent chemotherapy.[1,2] Therefore, the actual benefit of Selected Vegetables/Suns Soup, if any, to these patients is difficult to determine.

Treatment outcomes for another 9 patients were discussed briefly by the developer at a scientific conference in 1998.[2] The exact vegetable/herb combinations given to these individuals were not identified. However, all 9 patients reportedly benefited from treatment with Selected Vegetables/Suns Soup. Among the 9, 3 patients (2 with metastatic cancer of unspecified primary tumor type and 1 with metastatic adenocarcinoma of unknown primary tumor origin) did not receive concurrent conventional therapy. Complete tumor regression was observed in 2 of these 3 patients.[2] Among the remaining 6 patients, 3 (1 with metastatic cancer of unspecified primary tumor type, 1 with prostate cancer, and 1 with leiomyosarcoma that had metastasized to the lung, the breast, and the armpit) were treated with concurrent conventional therapy (radiation therapy, hormone therapy, and surgery, respectively). Complete tumor regression was observed in the patient with metastatic cancer of unspecified primary tumor type.[2] No information was provided about concurrent treatment for the remaining 3 individuals (1 with prostate cancer and 2 with colon cancer that had metastasized to the liver).[2] In view of the limited information presented, no conclusions can be drawn about the benefits of Selected Vegetables/Suns Soup for these 9 patients.

In 1992, the developer initiated a phase I/II clinical trial in the Czech Republic to test Selected Vegetables/Suns Soup as a treatment for non-small cell lung cancer.[4] Reviewed in [2,5] The results of this trial were reported in 1999.[4] The trial included a toxicity armto assess the tolerability of long-term administration of Selected Vegetables/Suns Soup and a survival armto assess the mixtures ability to improve survival in patients with advanced disease. Five patients with stage I cancer were included in the toxicity arm; these patients were treated with conventional therapy (surgery plus radiation therapy or radiation therapy alone) in addition to Selected Vegetables/Suns Soup. Nineteen patients with stage III or stage IV disease were included in the survival arm; 6 of these patients were treated with conventional therapy (radiation therapy alone or chemotherapy alone) in addition to Selected Vegetables/Suns Soup, and 13 were treated with conventional therapy (radiation therapy alone, chemotherapy alone, surgery plus radiation therapy, or chemotherapy plus radiation therapy) (12 patients) or best supportive care (1 patient) but not Selected Vegetables/Suns Soup. These latter 13 patients served as control subjects.

The intended duration of Selected Vegetables/Suns Soup treatment for all patients who received the mixture was 24 months. The intended daily dose was 30 g of freeze-dried powder (i.e., DSV; see General Information), mixed with water or other soup. Changes in body weight and changes in Karnofsky Performance Status (KPS) were measured in both arms of the trial. Median survival time was the primary endpoint in the survival arm.

In the toxicity arm, all 5 patients either gained weight or had no change in weight, which was measured twice, i.e., at study entry and 4 to 12 months later. The KPS score, which was also measured twice (at study entry and 3 months later), improved for 4 of the 5 patients and remained stable for the fifth. All 5 individuals were reported to be alive and well 24 months after diagnosis, and none developed a recurrent tumor during follow-up. The actual duration of Selected Vegetables/Suns Soup treatment for these patients ranged from more than 17 months to more than 24 months. From these data, the researchers concluded that Selected Vegetables/Suns Soup was safe, nontoxic, and well tolerated.[4]

In the survival arm, the average duration of Selected Vegetables/Suns Soup treatment was 7.3 months (range, 4-17 months). The median survival time from diagnosis for the 6 patients who ingested Selected Vegetables/Suns Soup was 15.5 months (range, 8-24+ months), compared with a median survival time from diagnosis of 4 months (range, 1-12 months) for the 13 patients in the control group. This difference in median survival time was reported to be statistically significant.[4]

As in the toxicity arm, body weight and KPS were measured twice in the survival arm. Body-weight measurements were made at study entry and at an average of 4.8 months later (range, 3-7 months) for the 6 patients in the Selected Vegetables/Suns Soup treatment group. Among the 13 patients in the control group, 9 had weight measurements made at study entry and at an average of 2.6 months later (range, 1-7 months); however, second body-weight measurements were not available for 4 control subjects. The average percent body-weight loss for the 6 patients in the Selected Vegetables/Suns Soup treatment group was 2.1%; for the 9 patients in the control group, the average percent body-weight loss was 11.6%. This 9.5% difference in body-weight loss was reported to be statistically significant. The 2 groups of patients had similar average body weights at study entry.[4]

KPS was measured at study entry and again 3 months later for all 6 patients in the Selected Vegetables/Suns Soup treatment group. For the 13 patients in the control group, KPS was measured at study entry and 1 to 3 months later. The first and second KPS scores did not differ substantially for the patients in the Selected Vegetables/Suns Soup treatment group. In fact, the second score was higher (indicating an improving condition) for 5 of the 6 patients; for the sixth patient, the first and second scores were the same. In contrast, the second KPS score was lower than the first (indicating a worsening condition) for all 13 patients in the control group. When the average KPS score at study entry for the control subjects was compared with the average score measured 1 to 3 months later, a statistically significant decline in KPS was noted. The average KPS score at study entry for the patients in the control group was not substantially different from the average KPS score at study entry for patients in the Selected Vegetables/Suns Soup treatment group.[4]

Although treatment with Selected Vegetables/Suns Soup was associated with substantial benefits in this trial, the results cannot be considered conclusive. Several major weaknesses in the design and execution of the trial could have affected the outcome. One major weakness is the small numbers of patients enrolled in the survival arm (6 patients in the Selected Vegetables/Suns Soup treatment group and 13 in the control group). Larger numbers of patients are needed to obtain reliable results. Another weakness is that the patients in the survival arm were not randomly assigned to the treatment group and the control group. The treatment group consisted of individuals who agreed to be treated with Selected Vegetables/Suns Soup; those who refused treatment comprised the control group. It is possible there were important, unidentified differences between the patients who agreed to be treated with Selected Vegetables/Suns Soup and those who did not. Nonetheless, in view of the positive results of this trial, CAPCAM recommended that a randomized phase III trial of Selected Vegetables/Suns Soup be conducted in patients with non-small cell lung cancer.[3]

In 2001, the developer reported clinical findings for an additional 16 patients who had stage III or stage IV non-small cell lung cancer and who had been treated with Selected Vegetables/Suns Soup.[5] The formulation ingested by these patients was Frozen SV, or FSV.[5,6] Among the 16 patients, 12 consumed FSV for a period of 2 months or more and were, therefore, considered eligible for analysis. The duration of FSV treatment for these 12 patients ranged from 5 months to more than 46 months. All of the patients were treated with conventional therapy (1 or more of the following: surgery, radiation therapy, chemotherapy, pleurodesis) in addition to treatment with Selected Vegetables/Suns Soup.

Among these 12 patients, 2 had no residual tumor after surgery to remove the primary tumor (n = 1) or surgery to remove the primary tumor and a contralateral lymph node metastasis (n = 1). The patient with the lymph node metastasis consumed FSV for more than 32 months and remained tumor free more than 30 months. This patient survived more than 33 months. The other patient ingested FSV for 14 months and survived 20 months. No information was available concerning the tumor-free period for this second patient.

Among the 10 remaining eligible patients, 2 were reported to have had a complete response to therapy. One of the patients had surgery to remove the primary tumor and then chemotherapy, radiation therapy, and FSV therapy to treat pleural effusion. This patient ingested FSV for 5 months and was still alive at the end of the study period (more than 8 months later). The other patient had surgery to remove the primary tumor, and then radiation therapy and FSV therapy to treat brain and bone metastases. This patient consumed FSV for 16 months and survived 22 months. No information was available about the duration of the tumor-free period for this latter patient.

Among the 8 remaining eligible patients, 3 had a partial response to treatment, and 4 had stable or progressive disease. Tumor response data were not available for 1 eligible patient.

Overall, the median survival time for the 12 eligible patients was 33.5 months, which is substantially longer than the median survival times cited by the developer for historical control subjects (range, 4-15 months).[5] Furthermore, the KPS score, which was measured at the start of FSV treatment and again 5 or more months later, improved for all but 1 of the eligible patients. On average, the second KPS score was 63% higher than the first score.[5]

As in the case of the phase I/II trial, the results of this nonconsecutive case series should be viewed with caution. Once again, a number of major weaknesses in the design of this clinical study could have influenced its outcome. Among these weaknesses are the following:

- The study included only a small number of patients.

- The survival analysis relied on comparisons with historical control subjects rather than an actual control group.

- All of the patients in the study were aware of the reported benefits of Selected Vegetables/Suns Soup and had actively sought treatment with it.

With respect to the third point, it is important to note that results obtained with such highly motivated, self-selected patients might not be typical of those obtained with most patients diagnosed with advanced non-small cell lung cancer.

Finally, the developer is currently conducting a phase II clinical trial to determine whether Selected Vegetables/Suns Soup can improve immune system function in patients with AIDS.[6] No information is available about the number of patients enrolled in this trial, and preliminary findings have been described for just 1 patient.

Reported use of Selected Vegetables/Suns Soup as a treatment for human cancer1

Enlarge Table

Principal reference citation   Type of study/report   Type of cancer   Numbers of patients: enrolled; treated; control2  Strongest benefit reported  Concurrent therapy3  Level of evidence score4 
[1] Anecdotal report (patent document) Metastatic kidney or non-small cell lung 4; 4; None Complete tumor regression, 3 patients Yes None
[2] Anecdotal report Various 9; 9; None Complete tumor regression, 3 patients Yes, 3 patients; No, 3 patients; Unknown, 3 patients None
[4] Phase I/II trial Early non-small cell lung (toxicity study) 5; 5; None Improved Karnofsky performance status, 4 patients Yes None
Advanced non-small cell lung (therapeutic study) 6; 6; 135 Improved median survival Yes (1 patient in control group received supportive care only) 3iA
[5] Nonconsecutive case series Advanced non-small cell lung 16; 12; None Improved median survival Yes, 10 of 12 evaluated patients 3iiiA

1. See text and glossary for more details and definitions of terms.
2. Number of patients treated plus number of patients control may not equal number of patients enrolled; number of patients enrolled = number of patients initially recruited/considered by the researchers who conducted a study; number of patients treated = number of enrolled patients who were given the treatment being studied AND for whom results were reported; historical control subjects are not included in number of patients enrolled.
3. Surgery, chemotherapy, radiation therapy, hormone therapy, pleurodesis given/allowed at same time as treatment with Selected Vegetables/Suns Soup.
4. For information about levels of evidence analysis and an explanation of the level of evidence score, see Levels of Evidence Analysis for Human Studies of Cancer Complementary and Alternative Medicine 6.
5. Control group consisted of patients who refused treatment with Selected Vegetables/Suns Soup.

References

1. Sun AS: Herbal Treatment of Malignancy. US Patent 5437866. August 1, 1995. Washington, DC: US Patent and Trademark Office, 1995. Available online. 2 Last accessed June 21, 2004. 
2. Sun A: Food therapy for non-small cell lung cancer. In: Comprehensive Cancer Care: Integrating Complementary and Alternative Therapies – A Conference for Health professionals, June 12-14, 1998. Breakout Session 405: Herbal Therapies. Available .online. 3 Last accessed June 21, 2004. 
3. Cancer Advisory Panel for Complementary and Alternative Medicine (CAPCAM).: Minutes of the First Meeting – July 8-9, 1999: Section X: Phase I/II study of stage III and IV non-small cell lung cancer patients taking a specific dietary supplement – Dr. Alexander Sun, Medical Director, Connecticut Institute of Aging and Cancer. Bethesda, Md: National Center for Complementary and Alternative Medicine, 2002. Available online. 4 Last accessed June 21, 2004. 

Adverse Effects

The only reported adverse effect with the use of Selected Vegetables/Suns Soup was a feeling of fullness or bloatedness when DSV was consumed in the amount specified in the phase I/II clinical trial.[1] No adverse effects were reported after ingestion of FSV.[2]

References

1. Sun AS, Ostadal O, Ryznar V, et al.: Phase I/II study of stage III and IV non-small cell lung cancer patients taking a specific dietary supplement. Nutr Cancer 34 (1): 62-9, 1999.  [PUBMED Abstract]

 

Level of Evidence for Selected Vegetables/Sun’s Soup

Existing data supporting the effectiveness of Selected Vegetables/Suns Soup as a treatment for cancer are limited and weak. To date, only 2 clinical studies have been reported in the peer-reviewed scientific literature.[1,2] These studies tested the ability of Selected Vegetables/Suns Soup to prolong the survival of patients with advanced non-small cell lung cancer. Although ingestion of Selected Vegetables/Suns Soup was associated with improved survival in both studies, the results may not be reliable because of the small numbers of patients included the studies (i.e., a total of 18 evaluable patients) and because of other major weaknesses in the designs of the studies. Furthermore, different formulations of Selected Vegetables/Suns Soup were used in the 2 studies, making a comparison of the results difficult. Information about the effectiveness of Selected Vegetables/Suns Soup as a treatment for other types of cancer is found only in anecdotal reports,[3,4] and no information is available about the safety or the efficacy of this treatment approach in pediatric patients. Additional larger, well-designed clinical studies that test identical formulations of vegetables and herbs are necessary to determine more clearly whether Selected Vegetables/Suns Soup can be useful in the treatment of non-small cell lung and other types of cancer.

References

1. Sun AS, Ostadal O, Ryznar V, et al.: Phase I/II study of stage III and IV non-small cell lung cancer patients taking a specific dietary supplement. Nutr Cancer 34 (1): 62-9, 1999.  [PUBMED Abstract]
2. Sun AS, Yeh HC, Wang LH, et al.: Pilot study of a specific dietary supplement in tumor-bearing mice and in stage IIIB and IV non-small cell lung cancer patients. Nutr Cancer 39 (1): 85-95, 2001.  [PUBMED Abstract]
3. Sun AS: Herbal Treatment of Malignancy. US Patent 5437866. August 1, 1995. Washington, DC: US Patent and Trademark Office, 1995. Available online. 2 Last accessed June 21, 2004. 
4. Sun A: Food therapy for non-small cell lung cancer. In: Comprehensive Cancer Care: Integrating Complementary and Alternative Therapies – A Conference for Health professionals, June 12-14, 1998. Breakout Session 405: Herbal Therapies. Available online. 3 Last accessed June 21, 2004. 

Changes to This Summary (06/22/2004)

The PDQ cancer information summaries are reviewed regularly and updated as new information becomes available. This section describes the latest changes made to this summary as of the date above.

New glossary terms were linked throughout this summary.

More Information

Additional Information about CAM Therapies

The National Cancer Institute Office of Cancer Complementary and Alternative Medicine 8 (OCCAM).

CAM on PubMed 9, a special subset of the PubMed scientific literature database created through a partnership between NCCAM and the National Library of Medicine.

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Glossary Terms

acquired immunodeficiency syndrome (ah-KWY-erd im-YOON-o-de-FISH-en-see SIN-drome)
AIDS. A disease caused by human immunodeficiency virus (HIV). People with AIDS are at an increased risk for developing certain cancers and for infections that usually occur only in individuals with a weak immune system

adenocarcinoma (AD-in-o-kar-sin-O-ma)
Cancer that begins in cells that line certain internal organs and that have glandular (secretory) properties.

adjunctive therapy
Another treatment used together with the primary treatment. Its purpose is to assist the primary treatment.

adrenal gland (ah-DREE-nal)
A small gland that produces steroid hormones, adrenaline, and noradrenaline, which help control heart rate, blood pressure, and other important body functions. There are two adrenal glands, one located on top of each kidney.

adverse effect
An unwanted side effect of treatment.

AIDS
Acquired immunodeficiency syndrome (ah-KWY-erd im-YOON-o-de-FISH-en-see SIN-drome). A disease caused by human immunodeficiency virus (HIV). People with AIDS are at an increased risk for developing certain cancers and for infections that usually occur only in individuals with a weak immune system.

anecdotal report
An incomplete description of the medical and treatment history of one or more patients. Anecdotal reports may be published in places other than peer-reviewed, scientific journals.

Angelica root
The root of any of a group of herbs called Angelica. It has been used in some cultures to treat certain medical problems, including gastrointestinal problems such as loss of appetite, feelings of fullness, and gas.

autoclave-resistant factor
A substance found in soybeans that may slow down or stop the spread of cancer. This substance does not break down in an autoclave (a device that uses high-pressure steam to kill microorganisms and clean medical equipment).

beta-glucan
A type of polysaccharide (string of sugar molecules) obtained from several types of mushrooms. It is being studied as a treatment for cancer and as an immune system stimulant.

bioavailable
The ability of a drug or other substance to be absorbed and used by the body. Orally bioavailable means that a drug or other substance that is taken by mouth can be absorbed and used by the body.

biochanin A
An isoflavone found in soy products. Soy isoflavones are being studied to see if they help prevent cancer.

breast
Glandular organ located on the chest. The breast is made up of connective tissue, fat, and breast tissue that contains the glands that can make milk. Also called mammary gland.

cancer of unknown primary origin
A case in which cancer cells are found in the body, but the place where the cells first started growing (the origin or primary site) cannot be determined.

carcinoma (KAR-si-NO-ma)
Cancer that begins in the skin or in tissues that line or cover internal organs.

cell
The individual unit that makes up all of the tissues of the body. All living things are made up of one or more cells.

chemotherapy (kee-mo-THER-a-pee)
Treatment with anticancer drugs.

clinical study
A type of research study that uses volunteers to test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called a clinical trial.

clinical trial
A type of research study that uses volunteers to test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called a clinical study.

colon (KO-lun)
The longest part of the large intestine, which is a tube-like organ connected to the small intestine at one end and the anus at the other. The colon removes water and some nutrients and electrolytes from partially digested food. The remaining material, solid waste called stool, moves through the colon to the rectum and leaves the body through the anus.

colorectal (ko-lo-REK-tul)
Having to do with the colon or the rectum.

complementary and alternative medicine
CAM. Forms of treatment that are used in addition to (complementary) or instead of (alternative) standard treatments. These practices generally are not considered standard medical approaches. CAM may include dietary supplements, megadose vitamins, herbal preparations, special teas, acupuncture, massage therapy, magnet therapy, spiritual healing, and meditation.

complete response
The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called a complete remission.

concurrent therapy
A treatment that is given at the same time as another.

contralateral
Having to do with the opposite side of the body.

control group
In a clinical trial, the group that does not receive the new treatment being studied. This group is compared to the group that receives the new treatment, to see if the new treatment works.

conventional therapy
A currently accepted and widely used treatment for a certain type of disease, based on the results of past research. Also called conventional treatment.

coumestan
An estrogen-like substance (phytoestrogen) made by some plants. Coumestans may have anticancer effects.

coumestrol
A type of coumestan. Coumestans are estrogen-like substances (phytoestrogens) made by some plants. Coumestans may have anticancer effects.

daidzein
An isoflavone found in soy products. Soy isoflavones are being studied in the prevention of cancer.

dietary supplement
Vitamins, minerals, or other substances taken by mouth, and intended as an addition to the diet.

dose
The amount of medicine taken, or radiation given, at one time.

efficacy
Effectiveness. In medicine, the ability of an intervention (for example, a drug or surgery) to produce the desired beneficial effect.

evaluable patients
Patients whose response to a treatment can be measured because enough information has been collected.

freeze-dried
A method used to dry substances, such as food, to make them last longer. The substance is frozen and then dried in a vacuum.

gastric (GAS-trik)
Having to do with the stomach.

genistein
An isoflavone found in soy products. Soy isoflavones are being studied to see if they help prevent cancer.

ginseng
An herb with a root that has been used in some cultures to treat certain medical problems. It may have anticancer effects.

gram
A unit of weight in the metric system. One gram is equal to one thousandth of a kilogram and is approximately 30-times less than an ounce.

hawthorn fruit
The fruit of the hawthorn tree or bush. It has been used in some cultures to treat certain medical problems, including heart problems and gastrointestinal problems.

Hedyotis diffusa
An herb used in traditional Chinese medicine to treat certain medical problems. It has been used to boost the immune system and may have anticancer effects.

historical control subject
An individual treated in the past and used in a comparison group when researchers analyze the results of a clinical study that had no control group. The use of a control, or comparison, group helps researchers determine the effects of a new treatment more accurately.

hormone therapy
Treatment that adds, blocks or removes hormones. For certain conditions (such as diabetes or menopause), hormones are given to adjust low hormone levels. To slow or stop the growth of certain cancers (such as prostate and breast cancer), synthetic hormones or other drugs may be given to block the body’s natural hormones. Sometimes surgery is needed to remove the gland that makes hormones. Also called hormonal therapy, hormone treatment, or endocrine therapy.

immune system (im-YOON)
The complex group of organs and cells that defends the body against infections and other diseases.

ingestion
Taking into the body by mouth.

injection
Use of a syringe and needle to push fluids or drugs into the body; often called a "shot."

inositol hexaphosphate
IP6. A substance that has been studied as a treatment for cancer. IP6 is found in large amounts in cereals and legumes. Also known as phytic acid.

intravenous (in-tra-VEE-nus)
IV. Within a blood vessel.

investigational
In clinical trials, refers to a drug (including a new drug, dose, combination, or route of administration) or procedure that has undergone basic laboratory testing and received approval from the US Food and Drug Administration (FDA) to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but be considered investigational in other diseases or conditions. Also called experimental.

isoflavone
An estrogen-like substance (phytoestrogen) made by some plants. Soy isoflavones are being studied in the prevention of cancer.

Karnofsky Performance Status
KPS. A standard way of measuring the ability of cancer patients to perform ordinary tasks. The Karnofsky Performance scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities. KPS may be used to determine a patient’s prognosis, to measure changes in a patients ability to function, or to decide if a patient could be included in a clinical trial.

laboratory study
Research done in a laboratory. These studies may use test tubes or animals to find out if a drug, procedure, or treatment is likely to be useful. Laboratory studies take place before any testing is done in humans.

lectin
A complex molecule that has both protein and sugars. Lectins are able to bind to the outside of a cell and cause biochemical changes in it. Lectins are made by both animals and plants.

leiomyosarcoma
A malignant (cancerous) tumor of smooth muscle cells that can arise almost anywhere in the body, but is most common in the uterus, abdomen, or pelvis.

lentinan
A beta-glucan (a type of polysaccharide) from the mushroom Lentinus edodes (shiitake mushroom). It has been studied in Japan as a treatment for cancer.

liver
A large organ located in the upper abdomen. The liver cleanses the blood and aids in digestion by secreting bile.

lung
One of a pair of organs in the chest that supplies the body with oxygen, and removes carbon dioxide from the body.

lymph node (limf node)
A rounded mass of lymphatic tissue that is surrounded by a capsule of connective tissue. Lymph nodes filter lymph (lymphatic fluid), and they store lymphocytes (white blood cells). They are located along lymphatic vessels. Also called a lymph gland.

malignant (ma-LIG-nant)
Cancerous. Malignant tumors can invade and destroy nearby tissue and spread to other parts of the body.

median survival time
The time from either diagnosis or treatment at which half of the patients with a given disease are found to be, or expected to be, still alive. In a clinical trial, median survival time is one way to measure how effective a treatment is.

metastasis (meh-TAS-ta-sis)
The spread of cancer from one part of the body to another. A tumor formed by cells that have spread is called a metastatic tumoror a metastasis.The metastatic tumor contains cells that are like those in the original (primary) tumor. The plural form of metastasis is metastases (meh-TAS-ta-seez).

metastatic (MET-uh-STAT-ik)
Having to do with metastasis, which is the spread of cancer from one part of the body to another.

molecular mass
The sum of the atomic masses of all atoms in a molecule, based on a scale in which the atomic masses of hydrogen, carbon, nitrogen, and oxygen are 1, 12, 14, and 16, respectively. For example, the molecular mass of water, which has two atoms of hydrogen and one atom of oxygen, is 18 (i.e., 2 + 16).

molecule
The smallest particle of a substance that has all of the physical and chemical properties of that substance. Molecules are made up of one or more atoms. If they contain more than one atom, the atoms can be the same (an oxygen molecule has two oxygen atoms) or different (a water molecule has two hydrogen atoms and one oxygen atom). Biological molecules, such as proteins and DNA, can be made up of many thousands of atoms.

mung bean
A type of bean grown in warm climates, usually for its seed and for bean sprouts. Mung bean may have anticancer effects.

non-small cell lung cancer
A group of lung cancers that includes squamous cell carcinoma, adenocarcinoma, and large cell carcinoma.

nonconsecutive case series
A clinical study that includes some, but not all, of the eligible patients identified by the researchers during the study registration period. This type of study does not usually have a control group.

nontoxic
Not harmful or destructive.

oral
By or having to do with the mouth.

ounce
A measure of weight (one-sixteenth pound) and volume (one-eighth cup).

partial response
A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission.

phase I/II trial
A trial to study the safety, dosage levels, and response to a new treatment.

phase II trial
A study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.

phase III trial
A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.

plant sterol
A plant-based compound that can compete with dietary cholesterol to be absorbed by the intestines, resulting in lower blood cholesterol levels. Plant sterols may have some effect in cancer prevention. Also called phytosterol.

pleural effusion
An abnormal collection of fluid between the thin layers of tissue (pleura) lining the lung and the wall of the chest cavity.

pleurodesis (PLOO-ro-DEE-sis)
A medical procedure that uses chemicals or drugs to cause inflammation and adhesion between the layers of the pleura (the tissue that covers the lungs and lines the interior wall of the chest cavity). This prevents the buildup of fluid in the pleural cavity. It is used as a treatment for severe pleural effusion.

preclinical study
Research using animals to find out if a drug, procedure, or treatment is likely to be useful. Preclinical studies take place before any testing in humans is done.

primary endpoint
The main result that is measured at the end of a study to see if a given treatment worked (e.g., the number of deaths or the difference in survival between the treatment group and the control group). What the primary endpoint will be is decided before the study begins.

progressive disease
Cancer that is growing, spreading, or getting worse.

prostate (PRAHS-tayt)
A gland in the male reproductive system. The prostate surrounds the part of the urethra (the tube that empties the bladder) just below the bladder, and produces a fluid that forms part of the semen.

protease inhibitor
A compound that interferes with the ability of certain enzymes to break down proteins. Some protease inhibitors can keep a virus from making copies of itself (for example, AIDS virus protease inhibitors), and some can prevent cancer cells from spreading.

quality of life
The overall enjoyment of life. Many clinical trials assess the effects of cancer and its treatment on the quality of life. These studies measure aspects of an individuals sense of well-being and ability to carry out various activities.

radiation therapy (ray-dee-AY-shun THER-ah-pee)
The use of high-energy radiation from x-rays, gamma rays, neutrons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy, implant radiation, or brachytherapy). Systemic radiation therapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that circulates throughout the body. Also called radiotherapy.

randomization
When referring to an experiment or clinical trial, the process by which animal or human subjects are assigned by chance to separate groups that compare different treatments or other interventions. Randomization gives each participant an equal chance of being assigned to any of the groups.

randomized clinical trial
A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient’s choice to be in a randomized trial.

recurrent cancer
Cancer that has returned after a period of time during which the cancer could not be detected. The cancer may come back to the same place as the original (primary) tumor or to another place in the body. Also called recurrence.

red date
The fruit of the jujube plant. It has been used in some cultures to treat certain medical problems.

regression
A decrease in the size of a tumor or in the extent of cancer in the body.

residual disease
Cancer cells that remain after attempts to remove the cancer have been made.

response
In medicine, an improvement related to treatment.

saponin
A substance found in soybeans and many other plants. Saponins may help lower cholesterol and may have anticancer effects.

sarcoma
A cancer of the bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue.

Scutellaria barbata
An herb that belongs to a group of herbs named the Scutellaria species or scullcap. Both the root and the above-ground part have been used to make herbal medicines. The root has been used in traditional Chinese medicine to treat lung cancer and other medical problems.

senega root
The root of an herb called Polygala senega. It has been used in some cultures to treat certain medical problems, including problems of the respiratory system.

shiitake mushroom
Lentinus edodes. A dark oriental mushroom widely used as a food. Several anticancer substances have been found in shiitake mushrooms, including lentinan, which has been studied in Japan as a treatment for stomach and colorectal cancer.

stage I non-small cell lung cancer
Cancer is in the lung only. Stage I is divided into stages IA and IB based on the size or location of the tumor.

stage III non-small cell lung cancer
Cancer has spread to structures near the lung; to the lymph nodes in the area that separates the two lungs (mediastinum); or to the lymph nodes on the other side of the chest or in the lower neck. Stage III is further divided into stage IIIA (usually can be resected which is sometimes treated with surgery) and stage IIIB (usually cannot be resected which is rarely treated with surgery).

stage IV kidney cancer
Cancer has spread beyond the kidney to 1 or more nearby lymph nodes and/or to other organs. Also called stage IV renal cell cancer.

stage IV non-small cell lung cancer
Cancer has spread to other parts of the body or to another lobe of the lungs.

statistically significant
Describes a mathematical measure of difference between groups. The difference is said to be statistically significant if it is greater than what might be expected to happen by chance alone. Also called significant.

subcutaneous
Beneath the skin.

supportive care
Care given to improve the quality of life of patients who have a serious or life-threatening disease. The goal of supportive care is to prevent or treat as early as possible the symptoms of the disease, side effects caused by treatment of the disease, and psychological, social, and spiritual problems related to the disease or its treatment. Also called palliative care, comfort care, and symptom management.

surgery (SER-juh-ree)
A procedure to remove or repair a part of the body or to find out whether disease is present. An operation.

tumor (TOO-mer)
An abnormal mass of tissue that results when cells divide more than they should or do not die when they should. Tumors may be benign (not cancerous), or malignant (cancerous). Also called neoplasm.

tumor model

A type of animal model which can be used to study the development and progression of diseases and to test new treatments before they are given to humans. Animals with transplanted human cancers or other tissues are called xenograft models.

Important:This information is intended mainly for use by doctors and other health care professionals. If you have questions about this topic, you can ask your doctor, or call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).A type of animal model which can be used to study the development and progression of diseases and to test new treatments before they are given to humans. Animals with transplanted human cancers or other tissues are called xenograft models.

Important:This information is intended mainly for use by doctors and other health care professionals. If you have questions about this topic, you can ask your doctor, or call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).A type of animal model which can be used to study the development and progression of diseases and to test new treatments before they are given to humans. Animals with transplanted human cancers or other tissues are called xenograft models.

Important:This information is intended mainly for use by doctors and other health care professionals. If you have questions about this topic, you can ask your doctor, or call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).A type of animal model which can be used to study the development and progression of diseases and to test new treatments before they are given to humans. Animals with transplanted human cancers or other tissues are called xenograft models.

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