Selected Vegetables/Sun's Soup (PDQ®): Complementary and alternative medicine - Health Professional Information [NCI]
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Selected Vegetables/Sun's Soup
This complementary and alternative medicine (CAM) information summary provides an overview of the use of Selected Vegetables/Sun's Soup as a treatment for people with cancer. The summary includes a brief history of Selected Vegetables/Sun's Soup and a review of animal and human studies. 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 Vegetables" and "Sun's Soup" are 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, two formulations of Selected Vegetables/Sun's Soup are marketed in the United States as dietary supplements.
- The vegetables and herbs in Selected Vegetables/Sun's Soup are thought to have anticancer and/or immune-system –stimulating properties.
- It has been reported that treatment with Selected Vegetables/Sun's 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/Sun's 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/Sun's 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 NCI Dictionary of Cancer Terms, which is oriented toward nonexperts. When a linked term is clicked, a definition will appear in a separate window.
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.
"Selected Vegetables" and "Sun's Soup" are 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.[1,2,3,4,5] The original formulation contained shiitake mushroom (Lentinus edodes [Berk.] Singer), mung bean (Phaseolus radiatus L.), Hedyotis diffusa Willd. (also known by the Chinese herbal name Bai Hua She She Cao), and barbat skullcap (Scutellaria barbata D. Don, also known by the Chinese herbal name Ban Zhi Lian).
A second formulation, specifically named "Selected Vegetables" ("SV"), was tested in a phase I/II clinical trial that involved patients with advanced non-small cell lung cancer (refer to the Human/Clinical Studies section of this summary for more information). 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 SV" or "DSV."
A third formulation, called "Frozen SV" or "FSV," has also been studied clinically in patients with advanced non-small cell lung cancer (refer to the Human/Clinical Studies section of this summary for more information). FSV, like SV/DSV, is marketed in the United States as a dietary supplement.
In the United States, dietary supplements are regulated as foods, not drugs. Therefore, premarket evaluation and approval by the U.S. 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/Sun's 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 (Glycine max [L.] Merr.), shiitake mushroom, mung bean, red date (Ziziphus jujuba Miller), scallion (Allium bakeri Regel), garlic (Allium sativum L.), leek (Allium fistulosum L.), lentil (Lens culinaris Medic.), Hawthorn fruit (Crataegus monogyna Jacquin and/or Crataegus oxyacantha L.), onion (Allium cepa L.), ginseng (Panax ginseng C.A. Meyer), Angelica root (Angelica sinensis), licorice (Glycyrrhiza glabra L.), dandelion root (Taraxacum officinale Weber), senega root (Polygala senega L.), ginger (Zingiber officinale Roscoe), olive (Olea europaea L.), sesame seed (Sesamum indicum L.), and parsley (Petroselinum crispum [P. Miller] Nyman ex A.W. Hill).[3,5]
Many of the ingredients in Selected Vegetables/Sun's Soup were chosen because previous biochemical research and traditional Chinese medicine suggested they contain molecules that have anticancer or immune-system –stimulating activity. Reviewed in [1,2,3,4,5]
Selected Vegetables/Sun's Soup is administered orally as part of the diet.[1,3,5] Studies in humans have not always specified a dose or an administration schedule , but daily doses 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.[3,5]
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/Sun's Soup as a treatment for cancer or any other disease.
In this summary, the specific formulation of Selected Vegetables/Sun's Soup given to individual patients or groups of patients will be identified wherever possible.
Selected Vegetables/Sun's 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 (Lentinus edodes [Berk.] Singer), mung bean (Phaseolus radiatus L.), Hedyotis diffusa Willd., and barbat skullcap (Scutellaria barbata D. Don) in the belief that these plant materials had anticancer and/or immune-system –stimulating properties.[1,2] After the relative appeared to benefit from this treatment (the relative was reported to be alive and cancer free for more than 13 years ), three additional patients (one with stage IV kidney cancer that had metastasized to the lungs, one with stage IV kidney cancer that had metastasized to the liver and to the lungs, and one 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). (Note: No explanation has been given for the omission of Hedyotis diffusa and barbat skullcap for these patients.) These additional patients were also said to benefit from vegetable/herb treatment. (Refer to the Human/Clinical Studies section of this summary for more information.)
In June 1992, the developer filed a patent application for the "Herbal treatment of malignancy," and a patent was awarded in August 1995. Also in June 1992, the developer initiated a clinical trial in the Czech Republic to test Selected Vegetables/Sun's Soup as a treatment for advanced non-small cell lung cancer. A second clinical study (a nonconsecutive case series) that also involved patients with advanced non-small cell lung cancer was completed in 1997. It is unclear, however, when patient accrual for this second study began. In both reports of the clinical study results, the authors concluded that patients who received Selected Vegetables/Sun's Soup had prolonged survival.[3,4] (Refer to the Human/Clinical Studies section of this summary for more information.)
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/Sun's Soup. (Refer to the Human/Clinical Studies section of this summary for more information.)
As noted previously (refer to the General Information section of this summary for more information), the proposed mechanism of action for Selected Vegetables/Sun's Soup involves anticancer and/or immune-system–stimulating activities associated with some of the ingredients. Reviewed in [1,2,3,4] The following types of compounds likely found in Selected Vegetables/Sun's Soup have been investigated for these activities: protease inhibitors and autoclave-resistant factors, which are found in soybeans (Glycine max L. Merr.); plant sterols; saponin; inositol hexaphosphate (IP6); beta-glucans; lectins; coumestans such as coumestrol; and isoflavones such as daidzein, genistein, biochanin A, and formononetin. Reviewed in [3,4]
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.[5,6] Reviewed in [7,8] Treatment with lentinan has been reported to prolong the survival of patients with gastric cancer [5,6] Reviewed in [7,8] and to improve their quality of life. However, lentinan may not be an active component in Selected Vegetables/Sun's Soup. This compound has a large molecular mass and is believed to have only limited oral bioavailability. Reviewed in [7,8,9] 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 [7,9]
Laboratory / Animal / Preclinical Studies
Only limited information is available from laboratory or animal studies of Selected Vegetables/Sun's Soup. The developer's patent document describes four animal experiments that used two mouse tumor models (mouse sarcoma S1509a, which was used in three of the experiments, and mouse Line 1 lung carcinoma, which was used in one experiment) and that evaluated shiitake mushroom (Lentinus edodes [Berk.] Singer), mung bean (Phaseolus radiatus L.), Hedyotis diffusa Willd., and barbat skullcap (Scutellaria barbata D. Don).
In these experiments, small groups of mice were fed either standard laboratory chow or laboratory chow that had been mixed with one or more of the four 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 two additional animal experiments were reported by the developer in a peer-reviewed scientific journal. One experiment was a repetition of the Line 1 lung carcinoma experiment that was described in the developer's 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/Sun's Soup; refer to the General Information section of this summary for more 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.
Human / Clinical Studies
The following information is summarized in a table located at the end of this section.
The use of Selected Vegetables/Sun's Soup as a treatment for human cancer has been investigated in only a limited manner. All available resources—the developer's patent document, the transcript of a presentation made at a scientific conference, and the published reports of two clinical studies [3,4]—have identified fewer than 50 treated patients.
As noted previously (refer to the History section of this summary for more information), the developer's patent document describes four patients with advanced cancer who reportedly benefited from treatment with Selected Vegetables/Sun's Soup. Among the four, three patients were said to have had complete tumor regression. However, two of the four patients were treated concurrently with chemotherapy and radiation therapy, and the remaining two were treated with concurrent chemotherapy.[1,2] Therefore, the actual benefit of Selected Vegetables/Sun's Soup, if any, to these patients is difficult to determine.
Treatment outcomes for another nine patients were discussed briefly by the developer at a scientific conference in 1998. The exact vegetable/herb combinations given to these individuals were not identified. However, all nine patients reportedly benefited from treatment with Selected Vegetables/Sun's Soup. Among the nine, three patients (two with metastatic cancer of unspecified primary tumor type and one with metastatic adenocarcinoma of unknown primary tumor origin) did not receive concurrent conventional therapy. Complete tumor regression was observed in two of these three patients. Among the remaining six patients, three (one with metastatic cancer of unspecified primary tumor type, one with prostate cancer, and one with leiomyosarcoma that had metastasized to the lung, breast, and 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. No information was provided about concurrent treatment for the remaining three individuals (one with prostate cancer and two with colon cancer that had metastasized to the liver). In view of the limited information presented, no conclusions can be drawn about the benefits of Selected Vegetables/Sun's Soup for these nine patients.
In 1992, the developer initiated a phase I/II clinical trial in the Czech Republic to test Selected Vegetables/Sun's Soup as a treatment for non-small cell lung cancer. Reviewed in [2,4] The results of this trial were reported in 1999. The trial included a "toxicity arm" to assess the tolerability of long-term administration of Selected Vegetables/Sun's Soup and a "survival arm" to assess the mixture's 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/Sun's Soup. Nineteen patients with stage III or stage IV disease were included in the survival arm; six of these patients were treated with conventional therapy (radiation therapy alone or chemotherapy alone) in addition to Selected Vegetables/Sun's 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 (one patient) but not Selected Vegetables/Sun's Soup. The remaining 13 patients served as control subjects.
The intended duration of Selected Vegetables/Sun's 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; refer to the General Information section of this summary for more 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 five 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 four of the five patients and remained stable for the fifth. All five 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/Sun's 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/Sun's Soup was safe, nontoxic, and well tolerated.
In the survival arm, the average duration of Selected Vegetables/Sun's Soup treatment was 7.3 months (range, 4–17 months). The median survival time from diagnosis for the six patients who ingested Selected Vegetables/Sun's Soup was 15.5 months (range, 8 to more than 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.
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 six patients in the Selected Vegetables/Sun's Soup treatment group. Among the 13 patients in the control group, nine had weight measurements made at study entry and at an average of 2.6 months later (range, 1–7 months); however, the second body-weight measurements were not available for four control subjects. The average percent body-weight loss for the six patients in the Selected Vegetables/Sun's Soup treatment group was 2.1%; for the nine 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 two groups of patients had similar average body weights at study entry.
KPS was measured at study entry and again 3 months later for all six patients in the Selected Vegetables/Sun's 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/Sun's Soup treatment group. In fact, the second score was higher (indicating an improving condition) for five of the six patients; for the sixth patient, the first and second scores were the same. 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/Sun's Soup treatment group.
Although treatment with Selected Vegetables/Sun's 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 (six patients in the Selected Vegetables/Sun's 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/Sun's 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/Sun's Soup and those who did not.
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/Sun's Soup. The formulation ingested by these patients was Frozen SV, or FSV.[4,5] Among the 16 patients, 12 consumed FSV for a period of 2 months or more and were 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 (one or more of the following: surgery, radiation therapy, chemotherapy, or pleurodesis) in addition to treatment with Selected Vegetables/Sun's Soup.
Among these 12 patients, two 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 ten remaining eligible patients, two 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 the remaining patient.
Among the eight remaining eligible patients, three had a partial response to treatment, and four had stable or progressive disease. Tumor response data were not available for one 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). Furthermore, the KPS score, which was measured at the start of FSV treatment and again 5 or more months later, improved for all but one of the eligible patients. On average, the second KPS score was 63% higher than the first score.
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/Sun's 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.
The developer is currently conducting a phase II clinical trial to determine whether Selected Vegetables/Sun's Soup can improve immune system function in patients with acquired immunodeficiency syndrome. No information is available about the number of patients enrolled in this trial, and preliminary findings have been described for just one patient.
A randomized phase III trial (NCT00246727) of patients with stage IIIB or stage IV non-small cell lung cancer is being conducted. The primary objective is to compare the survival of patients receiving Selected Vegetables Sun's Soup dietary supplement with those receiving a placebo while undergoing treatment with best supportive care (i.e., radiation therapy, surgery, or palliative care).
Reported Use of Selected Vegetables/Sun's Soup as a Treatment for Human Cancera
|Principal Reference Citation||Type of Study/Report||Type of Cancer||No. of Patients: Enrolled; Treated; Controlb||Strongest Benefit Reported||Concurrent Therapyc||Level of Evidence Scored|
|No. = number.|
|a See text and glossary for more details and definitions of terms.|
|b Number of patients treated plus number of patients controlled 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 administered the treatment being studiedAND for whom results were reported; historical control subjects are not included in number of patients enrolled.|
|c Surgery, chemotherapy, radiation therapy, hormone therapy, pleurodesis administered/allowed at same time as treatment with Selected Vegetables/Sun's Soup.|
|d For information about levels of evidence analysis and an explanation of the level of evidence score, seeLevels of Evidence for Human Studies of Cancer Complementary and Alternative Medicine.|
|||Anecdotal report(patent document)||Metastatic kidney or non-small cell lung||4; 4; None||Complete tumor regression, 3 patients||Yes||None|
|||Anecdotal report||Various||9; 9; None||Complete tumor regression, 3 patients||Yes, 3 patients; no, 3 patients; unknown, 3 patients||None|
|||Phase I/II trial||Early non-small cell lung (toxicity study)||5; 5; None||Improved Karnofsky performance status, 4 patients||Yes||None|
|||Nonconsecutive case series||Advanced non-small cell lung||16; 12; None||Improved median survival||Yes, 10 of 12 evaluated patients||3iiiA|
The only reported adverse effect with the use of Selected Vegetables/Sun's Soup was a feeling of fullness or bloatedness when freeze-dried Selected Vegetables (SV) was consumed in the amount specified in the phase I/II clinical trial. No adverse effects were reported after ingestion of frozen SV.
Summary of the Evidence for Selected Vegetables / Sun's Soup
Existing data supporting the effectiveness of Selected Vegetables/Sun's Soup as a treatment for cancer are limited and weak. To date, only two clinical studies have been reported in the peer-reviewed scientific literature.[1,2] These studies tested the ability of Selected Vegetables/Sun's Soup to prolong the survival of patients with advanced non-small cell lung cancer. Although ingestion of Selected Vegetables/Sun's Soup was associated with improved survival in both studies, the results may not be reliable because of the small numbers of patients included in the studies (i.e., a total of 18 evaluable patients) and because of other major weaknesses in the designs of the studies. Different formulations of Selected Vegetables/Sun's Soup were used in the two studies, making a comparison of the results difficult. Information about the effectiveness of Selected Vegetables/Sun's 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/Sun's Soup can be useful in the treatment of non-small cell lung and other types of cancer.
Separate levels of evidence scores are assigned to qualifying human studies on the basis of statistical strength of the study design and scientific strength of the treatment outcomes (i.e., endpoints) measured. The resulting two scores are then combined to produce an overall score. For additional information about levels of evidence analysis, refer to Levels of Evidence for Human Studies of Cancer Complementary and Alternative Medicine.
Changes to This Summary (08 / 16 / 2012)
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.
Editorial changes were made to this summary.
This summary is written and maintained by the PDQ Cancer Complementary and Alternative Medicine Editorial Board, which is editorially independent of NCI. The summary reflects an independent review of the literature and does not represent a policy statement of NCI or NIH. More information about summary policies and the role of the PDQ Editorial Boards in maintaining the PDQ summaries can be found on the About This PDQ Summary and PDQ NCI's Comprehensive Cancer Database pages.
About This PDQ Summary
Purpose of This Summary
This PDQ cancer information summary for health professionals provides comprehensive, peer-reviewed, evidence-based information about the use of selected vegetables/Sun's soup in the treatment of people with cancer. It is intended as a resource to inform and assist clinicians who care for cancer patients. It does not provide formal guidelines or recommendations for making health care decisions.
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National Cancer Institute: PDQ® Selected Vegetables/Sun's Soup. Bethesda, MD: National Cancer Institute. Date last modified <MM/DD/YYYY>. Available at: http://cancer.gov/cancertopics/pdq/cam/vegetables-sun-soup/HealthProfessional. Accessed <MM/DD/YYYY>.
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Last Revised: 2012-08-16
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