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Phase III Randomized Study of a Dietary Supplement Comprising Selected Vegetables-Sun's Soup in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Undergoing Treatment With Best Supportive Care
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Selected Vegetables-Sun's Soup Dietary Supplement in Treating Patients Who Are Undergoing Supportive Care for Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Basic Trial Information
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Protocol IDs
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Phase III
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Treatment
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Approved-not yet active
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18 and over
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Other
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SFC-SV002 NCT00246727
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Objectives Primary - Compare the survival of patients with stage IIIB or IV non-small cell lung cancer receiving selected vegetables (SV)-Sun's soup dietary supplement vs placebo.
Secondary - Compare tumor response in patients receiving SV dietary supplement vs placebo.
- Compare the quality of life of patients receiving SV dietary supplement vs placebo.
- Evaluate the toxicity of SV dietary supplement in these patients.
Entry Criteria Disease Characteristics:
- Pathologically and radiographically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC) of 1 of the following cell types:
- Squamous cell
- Adenocarcinoma
- Bronchioalveolar
- Large cell
- Undifferentiated
- Not otherwise specified
- Disease diagnosed within the past 2 months
- Meets 1 of the following criteria:
- Measurable disease
- Measurable disease is defined as lesions that can be accurately measured in ≥ 1 dimension as ≥ 2.0 cm by conventional techniques OR as ≥ 1.0 cm by spiral CT scan
- Disease restricted to a solitary lesion must have neoplastic nature confirmed by cytology or histology
- Lesions situated in a previously irradiated area are not considered measurable disease
- Nonmeasurable disease
- Nonmeasurable disease is defined as all other lesions, including small lesions (longest diameter < 2.0 cm with conventional techniques and < 1.0 cm with spiral CT scan) and truly nonmeasurable lesions
- Lesions considered to be truly nonmeasurable include any of the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural or pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis or pulmonitis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Refused or failed prior chemotherapy
Prior/Concurrent Therapy:
- See Disease Characteristics
- More than 5 years since prior chemotherapy
- No prior radiation to the area of measurable or active tumor
- Concurrent radiotherapy allowed
- No concurrent hormonal therapy
- Postmenopausal women already receiving estrogens or progestins as hormone replacement therapy may continue to do so during study treatment
- No concurrent glucocorticoids except for treatment of adrenal failure or septic shock
- No concurrent usage of illicit drugs or other immune-suppressing or immune-modulating drugs
- No concurrent chemotherapy
Patient Characteristics:
- ECOG performance status 0 or 1
- Life expectancy ≥ 3 months
- Must be able to eat solid food and study dietary supplement or placebo
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST < 2.5 times ULN
- Creatinine < 1.5 times ULN
- WBC > 4,000/mm³
- Platelet count > 100,000/mm³
- Neutrophil count > 1,500/mm³
- Hemoglobin ≥ 9 g/dL (males) or ≥ 8.5 g/dL (females)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No chronic diarrhea (≥ 3 stools/day for 15 days) within the past 30 days
- No unexplained fever (≥ 38.5°C) for 7 consecutive days
- No previous diagnosis of any other malignancy except non-metastatic nonmelanoma skin cancer or carcinoma in situ of the cervix
- No significant cardiac disease, including any of the following:
- Uncontrolled high blood pressure
- Unstable angina
- Congestive heart failure
- Myocardial infarction within the past year
- Serious cardiac arrhythmia requiring medication
- No acute infection, except for herpes viruses (i.e., cytomegalovirus, Epstein-Barr virus, herpes zoster virus, or herpes simplex-1)
- No other serious underlying medical condition that would limit life expectancy to < 2 years
- No psychiatric illness that would preclude study compliance
- No known allergy to ≥ 1 component of study treatment, including any of the following:
- 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 seeds
- Parsley
Expected Enrollment 150A total of 150 patients will be accrued for this study. Outcomes Primary Outcome(s)Survival time
Secondary Outcome(s)Mean survival time Tumor response Quality of life by EORTC QLQ-C30 questionnaire and EORTC QLQ-LC13 (lung cancer specific questionnaire) at baseline and at weeks 3, 6, 9, 12, 15, 18, 21, 24, 36, 48, 60, 72, and 96 Fatigue by MFI-20 questionnaire ECOG performance status Hematological and immunological parameters
Outline This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1) and disease stage (IIIB vs IV). Patients with stage IIIB disease are further stratified according to presence of pleural or pericardial effusion (yes vs no). Patients with stage IV disease are further stratified according to presence of brain metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral selected vegetables-Sun's soup dietary supplement once daily for 3 years in the absence of unacceptable toxicity.
- Arm II: Patients receive oral placebo once daily for 3 years in the absence of unacceptable toxicity.
All patients receive best supportive care, including radiotherapy, surgery, and palliative care, for 3 years. Quality of life is assessed at baseline and at weeks 3, 6, 9, 12, 15, 18, 21, 24, 36, 48, 60, 72, and 96. After completion of study treatment, patients are followed periodically.
Trial Contact Information
Trial Lead Organizations Sun Farm Corporation | | | Henry Sacks, MD, PhD, Principal investigator | | | |
Registry Information | | Official Title | | Effects of a Dietary Supplement (SV) on Advanced Non Small Cell Lung Cancer Patients Treated with Best Supportive Care (BSC): A Randomized Double-Blind Placebo Controlled Study | | Trial Start Date | | 2008-03-01 (estimated) | | Trial Completion Date | | 2011-12-31 (estimated) | | Registered in ClinicalTrials.gov | | NCT00246727 | | Date Submitted to PDQ | | 2006-10-17 | | Information Last Verified | | 2008-12-28 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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