Non-small Cell Lung CancerPhase 3NCT00246727
Effects of Selected Vegetable and Herb Mix (SV) on Advanced Non-small Cell Lung Cancer
A Phase 3 study testing Selected Vegetable and Herb Mix in people with Non-small Cell Lung Cancer, run by Sun Farm Corporation at 1 site in United States.
Trial summary
The primary objective of these two studies is to test the hypothesis that the daily ingestion of a dietary supplement, Selected Vegetables and Herbs Mix (SV), which consists of non-toxic botanicals containing known anti-cancer and/or immune enhancing components, may prolong the survival time of stage IIIB/IV non-small… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Selected Vegetable and Herb Mix
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological and radiographic documented stage IIIB/IV NSCLC (squamous, adenocarcinoma, bronchioloalveolar, large cell, undifferentiated or not otherwise specified non-small cell carcinoma) diagnosed less than two months prior to randomization. Patients must have ECOG performance status of 0-1 and life expectancy >3 months.
- Patients must never have been diagnosed with any malignancy other than the current NSCLC, except for non-metastatic non-melanoma skin cancer, or cancer in situ of the cervix.
- Patients must be >18 years of age.
- Patients must demonstrate the ability and willingness to eat solid food and SV/placebo.
- Patients must demonstrate the ability and willingness to give informed consent.
- Patients must demonstrate the ability and willingness to follow the study requirements.
Who cannot join
- Laboratory criteria for exclusion within 14 days prior to randomization.
- Liver function: bilirubin > 1.5x upper limit of normal (ULN) and SGOT (AST) > 2.5x ULN.
- Renal function: Serum creatinine >1.5x ULN
- Bone marrow function: white blood cell (WBC) < 4,000/µl; platelet count < 100,000 mm3; neutrophil count < 1,500/mm3.
- Hemoglobin <9 gm/dl for males; < 8.5 gm/dl for females.
- Unexplained temperature > 38.5° C for any 7 consecutive days or chronic diarrhea defined as > 3 stools/day persisting for 15 consecutive days, within the 30 days prior to randomization.
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- Prior chemotherapy within 5 years.
- Prior radiation to the area of measurable or active tumor.
- Significant cardiac disease (i.e. uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous year) or serious cardiac arrhythmia requiring medication.
- Evidence of clinically significant neuropathy (> Grade 1) by physical exam.
- Patients must not be pregnant or breast-feeding. Female patients of child-bearing potential must have a negative pregnancy test performed within 72 hours prior to randomization. Women of child-bearing potential must agree not to become pregnant while participating in the study.
- Active acute infection, except for Herpes viruses (cytomegalovirus [CMV], Epstein Barr virus [EBV], herpes zoster virus [HZV], herpes simplex virus 1 [HSV 1]).
- A serious underlying medical condition other than NSCLC such that life expectancy is less than 2 years.
- Psychiatric illness that may affect the patient's compliance with the treatment.
- Current use of illicit drugs, glucocorticoids other than those necessary for concurrent radiotherapy, adrenal failure or septic shock, or other immune-suppressing or immune-modulating drugs. Glucocorticoids for anti-emetic prophylaxis and therapy should only be used as a last resort.
- A known allergy to one or more components of SV, namely soy beans, mushrooms, mung beans, red dates, scallion, garlic, lentil beans, leek, hawthorn fruit, onions, ginseng, angelica root, Chinese licorice, dandelion root, Senegal root, ginger, olives, sesame seed and parsley.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai School of Medicine
New York, New York, 10029
Henry S Sacks, MD, Ph.D, 212-241-7856, henry.sacks@mssm.edu
Henry S Sacks, MD, Ph.D
About this study
Official title: Study 1: Effects of a Dietary Supplement (SV) on Advanced NSCLC Treated With Chemotherapy: A Randomized Double Blind Placebo Controlled Study; Study 2: Effects of a Dietary Supplement (SV) on Advanced NSCLC Treated With Best Supportive Care: A Randomized Double Blind Placebo Controlled Study
The primary objective of these two studies is to test the hypothesis that the daily ingestion of a dietary supplement, Selected Vegetables and Herbs Mix (SV), which consists of non-toxic botanicals containing known anti-cancer and/or immune enhancing components, may prolong the survival time of stage IIIB/IV non-small cell lung cancer (NSCLC) patients. Either SV or placebo will be added to their daily diet in a double-blind randomized fashion, so that there will be 2 chances out of 3 of receiving SV and 1 chance out of 3 of receiving placebo.
- Study 1: For newly diagnosed patients who will be receiving or have received less than 4 weeks of, a standard chemotherapy regimen.
- Study 2: For those who have stopped or refuse standard chemotherapy but will receive best supportive care.
Read the detailed description
Carcinoma of the lung is the leading cause of cancer related deaths in North America. Non-small Cell Lung Cancer (NSCLC) causes the death of more than 400,000 patients annually in the US and Western Europe. The benefit of conventional therapies, such as chemotherapy and radiotherapy, for unresectable stage IIIB and IV NSCLC patients is small; the generally accepted median survival time of late stage patients has remained 4-6 months in the "Supportive Care" group and 6-9 months in the chemotherapy treatment group; the one-year survival is about 20%. Ideal Treatment for NSCLC: The toxicity of chemotherapy and side-effects of radiotherapy to the quality of life of the patients have been a major issue in cancer treatments. It has been significant enough that many patients choose to forgo standard treatments. Furthermore, the current chemotherapy for advanced NSCLC is quite expensive, about $50,000 to $100,000 per year. Therefore, an ideal treatment for advanced NSCLC patients should meet the following criteria:
- Prolong patient survival.
- Minimal toxicity.
- Improvement in the patient's quality of life.
- Relatively inexpensive. A phytomix consisting of selected vegetables and herbs appears to meet all these criteria. The phytomix consists of 19 vegetable and herbs in a highly concentrated form. These vegetables and herbs were selected based on their anti-cancer and immune-enhancing activities. Each batch of raw materials has gone through a very strict quality control (QC) scheme to make sure the product meets our QC standards and devoid of deleterious contaminations, such as heavy metals, pesticides, aflatoxin, and microorganisms. The manufacturing process is tightly controlled to ensure batch-to-batch consistency. The final product, a 20 gram freeze-dried powder, is sealed in a pouch. In our previous studies, patients who ingested phytomix daily for 17-60 months showed no clinical sign of adverse effect.
The Objectives of the proposed studies are to evaluate the benefits and adverse reactions of adding SV to the daily diet of cancer patients who are willing to undergo the chemotherapy (Study 1) or those who refuse chemotherapy (Study 2).
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Selected Vegetable and Herb Mix
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selected Vegetable and Herb MixDrug
The phytomix consists of 19 vegetable and herbs in a highly concentrated form. These vegetables and herbs were selected based on their anti-cancer and immune-enhancing activities. Each batch of raw materials has gone through a very strict quality control (QC) scheme to make sure the product meets our QC standards and devoid of deleterious contaminations, such as heavy metals, pesticides, aflatoxin, and microorganisms. The manufacturing process is tightly controlled to ensure batch-to-batch consistency. The final product, a 20 gram freeze-dried powder, is sealed in a pouch. In our previous studies, patients who ingested phytomix daily for 17-60 months showed no clinical sign of adverse effect.
| Study group | Role | What they receive |
|---|---|---|
| Study 1: Chemotherapy plus SV or Placebo | Placebo comparator | For newly diagnosed patients who will be receiving or have received less than 4 weeks of a standard chemotherapy regimen. Receives: Drug: Selected Vegetable and Herb Mix |
| Study 2: SV vs Placebo without chemotherapy | Placebo comparator | For those who have stopped or refuse standard chemotherapy but will receive best supportive care. Receives: Drug: Selected Vegetable and Herb Mix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Time
Measured: Median Survival Time (MST)
Secondary outcomes (3)
Tumor response
Measured: After one month of treatment
Quality of Life
Measured: For length of study while on active treatment
Toxicity of SV
Assessed anually at Safety Monitoring Board
Measured: Annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study startDec 2005
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Farm Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Henry S Sacks, MD, Ph.D, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246727
- Sponsor's protocol ID
- SV-001 and SV-002
- Status last verified
- Oct 2011
- First submitted
- 27 Oct 2005
- Last updated
- 31 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study 1: Effects of a Dietary Supplement (SV) on Advanced NSCLC Treated With Chemotherapy: A Randomized Double Blind Placebo Controlled Study; Study 2: Effects of a Dietary Supplement (SV) on Advanced NSCLC Treated With Best Supportive Care: A Randomized Double Blind Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT00246727
- Acronym / sponsor ID
- SV-001 and SV-002
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sun Farm CorporationUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Dec 2005
- Primary completion
- Dec 2014 (estimated)
- First posted
- 31 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of these two studies is to test the hypothesis that the daily ingestion of a dietary supplement, Selected Vegetables and Herbs Mix (SV), which consists of non-toxic botanicals containing known anti-cancer and/or immune enhancing components, may prolong the survival time of stage IIIB/IV non-small cell lung cancer (NSCLC) patients. Either SV or placebo will be added to their daily diet in a double-blind randomized fashion, so that there will be 2 chances out of 3 of receiving SV and 1 chance out of 3 of receiving placebo.
- Study 1: For newly diagnosed patients who will be receiving or have received less than 4 weeks of, a standard chemotherapy regimen.
- Study 2: For those who have stopped or refuse standard chemotherapy but will receive best supportive care.
Detailed description
Carcinoma of the lung is the leading cause of cancer related deaths in North America. Non-small Cell Lung Cancer (NSCLC) causes the death of more than 400,000 patients annually in the US and Western Europe. The benefit of conventional therapies, such as chemotherapy and radiotherapy, for unresectable stage IIIB and IV NSCLC patients is small; the generally accepted median survival time of late stage patients has remained 4-6 months in the "Supportive Care" group and 6-9 months in the chemotherapy treatment group; the one-year survival is about 20%. Ideal Treatment for NSCLC: The toxicity of chemotherapy and side-effects of radiotherapy to the quality of life of the patients have been a major issue in cancer treatments. It has been significant enough that many patients choose to forgo standard treatments. Furthermore, the current chemotherapy for advanced NSCLC is quite expensive, about $50,000 to $100,000 per year. Therefore, an ideal treatment for advanced NSCLC patients should meet the following criteria:
- Prolong patient survival.
- Minimal toxicity.
- Improvement in the patient's quality of life.
- Relatively inexpensive. A phytomix consisting of selected vegetables and herbs appears to meet all these criteria. The phytomix consists of 19 vegetable and herbs in a highly concentrated form. These vegetables and herbs were selected based on their anti-cancer and immune-enhancing activities. Each batch of raw materials has gone through a very strict quality control (QC) scheme to make sure the product meets our QC standards and devoid of deleterious contaminations, such as heavy metals, pesticides, aflatoxin, and microorganisms. The manufacturing process is tightly controlled to ensure batch-to-batch consistency. The final product, a 20 gram freeze-dried powder, is sealed in a pouch. In our previous studies, patients who ingested phytomix daily for 17-60 months showed no clinical sign of adverse effect.
The Objectives of the proposed studies are to evaluate the benefits and adverse reactions of adding SV to the daily diet of cancer patients who are willing to undergo the chemotherapy (Study 1) or those who refuse chemotherapy (Study 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study 1: Chemotherapy plus SV or Placebo | Placebo comparator | Drug: Selected Vegetable and Herb MixFor newly diagnosed patients who will be receiving or have received less than 4 weeks of a standard chemotherapy regimen. |
| Study 2: SV vs Placebo without chemotherapy | Placebo comparator | Drug: Selected Vegetable and Herb MixFor those who have stopped or refuse standard chemotherapy but will receive best supportive care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathological and radiographic documented stage IIIB/IV NSCLC (squamous, adenocarcinoma, bronchioloalveolar, large cell, undifferentiated or not otherwise specified non-small cell carcinoma) diagnosed less than two months prior to randomization. Patients must have ECOG performance status of 0-1 and life expectancy >3 months.
- Patients must never have been diagnosed with any malignancy other than the current NSCLC, except for non-metastatic non-melanoma skin cancer, or cancer in situ of the cervix.
- Patients must be >18 years of age.
- Patients must demonstrate the ability and willingness to eat solid food and SV/placebo.
- Patients must demonstrate the ability and willingness to give informed consent.
Key exclusion criteria (16 listed)
- Laboratory criteria for exclusion within 14 days prior to randomization.
- Unexplained temperature > 38.5° C for any 7 consecutive days or chronic diarrhea defined as > 3 stools/day persisting for 15 consecutive days, within the 30 days prior to randomization.
- Prior chemotherapy within 5 years.
- Prior radiation to the area of measurable or active tumor.
- Significant cardiac disease (i.e. uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous year) or serious cardiac arrhythmia requiring medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selected Vegetable and Herb MixThe phytomix consists of 19 vegetable and herbs in a highly concentrated form. These vegetables and herbs were selected based on their anti-cancer and immune-enhancing activities. Each batch of raw materials has gone through a very strict quality control (QC) scheme to make sure the product meets our QC standards and devoid of deleterious contaminations, such as heavy metals, pesticides, aflatoxin, and microorganisms. The manufacturing process is tightly controlled to ensure batch-to-batch consistency. The final product, a 20 gram freeze-dried powder, is sealed in a pouch. In our previous studies, patients who ingested phytomix daily for 17-60 months showed no clinical sign of adverse effect. | Drug | Study 1: Chemotherapy plus SV or Placebo, Study 2: SV vs Placebo without chemotherapy |
Primary outcome
Survival Time
Time frame: Median Survival Time (MST)
3 secondary outcomes
Tumor response
Time frame: After one month of treatment
Quality of Life
Time frame: For length of study while on active treatment
Toxicity of SV
Time frame: Annually
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry S Sacks, MD, Ph.D principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Selected Vegetable and Herb Mix in people with Non-small Cell Lung Cancer, run by Sun Farm Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henry Sacks, MD, Ph.D (212-241-7856, henry.sacks@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Time (time frame: Median Survival Time (MST)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2011.