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
18 Years
N/A
Both
Non-small Cell Lung Cancer
Trial Information
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
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:
1. Prolong patient survival.
2. Minimal toxicity.
3. Improvement in the patient's quality of life.
4. 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).
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Survival Time
Outcome Time Frame:
Median Survival Time (MST)
Safety Issue:
No
Principal Investigator
Henry S Sacks, MD, Ph.D
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mount Sinai School of Medicine
Authority:
United States: Food and Drug Administration
Study ID:
SV-001 and SV-002
NCT ID:
NCT00246727
Start Date:
December 2005
Completion Date:
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Mount Sinai School of Medicine | New York, New York 10029 |
