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

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Approved-not yet active 18 and over Other SFC-SV002 NCT00246727

Objectives

Primary

1. 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

1. Compare tumor response in patients receiving SV dietary supplement vs placebo.
2. Compare the quality of life of patients receiving SV dietary supplement vs placebo.
3. 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

A total of 150 patients will be accrued for this study.

Outcomes

Survival time

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		Ph: 212-241-7856 Email: henry.sacks@mssm.edu

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