Status:
UNKNOWN
Effects of Selected Vegetable and Herb Mix (SV) on Advanced Non-small Cell Lung Cancer
Lead Sponsor:
Sun Farm Corporation
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 co...
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 E...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00246727
Start Date
December 1 2005
Last Update
October 31 2011
Active Locations (1)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029