Fruit and Vegetable Extracts in Treating Patients With Stage I-IV, Stage IVA/IVB Head and Neck Cancer

Phase 2

Completed

Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. Fruit and vegetable extracts may be effective in preventing the recurrence or further development of head and neck cancer.

PURPOSE: This randomized phase II trial is studying how well fruit and vegetable extracts work in preventing the recurrence of stage I, stage II, stage III, stage IVA, or stage IVB head and neck cancer.

Detailed Description: OBJECTIVES:

* Compare the disease-free survival of patients with stage I-IV (including stage IVA and IVB) head and neck cancer treated with fruit and vegetable extracts vs placebo.

* Compare the effect of these extracts on biomarkers (p27 expression, cell proliferation of Ki-67, DNA damage, and T-cell function) in these patients.

* Correlate changes in biomarkers with other factors (e.g., site and stage of the original tumors, tobacco/alcohol use, or depression) in patients treated with these extracts.

* Compare serum carotenoids and antioxidant levels (vitamins A, C, and E) at baseline and posttreatment in patients treated with these extracts.

OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are stratified according to tobacco use (yes vs no), alcohol consumption (yes vs no), and tumor stage at diagnosis (I vs II vs III vs IVA vs IVB). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral fruit and vegetable extracts twice daily.

* Arm II: Patients receive oral placebo twice daily. Treatment in both arms continues for 12 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed annually for 5 years.

PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study within 18 months.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
Expression of p27 Cell Cycle Regulatory Protein at Baseline and Week 12	baseline and 12 weeks	Expression of p27 cell cycle regulatory protein at baseline and week 12. p27 is measured continuously. Lower values are worse.

Secondary Outcome Measures

Name	Time	Method
Cell Proliferation (Ki-67) at Baseline and Week 12	baseline and 12 weeks	Cell proliferation (Ki-67) at baseline and week 12. Ki67 is a cell proliferation associated nuclear protein. It is measured continuously. Higher values are worse.

Locations (28): CCOP - Santa Rosa Memorial Hospital
🇺🇸
Santa Rosa, California, United States
Redwood Regional Medical Group
🇺🇸
Santa Rosa, California, United States
CCOP - Christiana Care Health Services
🇺🇸
Newark, Delaware, United States
MBCCOP - Howard University Cancer Center
🇺🇸
Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center
🇺🇸
Miami Beach, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
🇺🇸
Miami, Florida, United States
MBCCOP - JHS Hospital of Cook County
🇺🇸
Chicago, Illinois, United States
CCOP - Central Illinois
🇺🇸
Decatur, Illinois, United States
CCOP - Northern Indiana CR Consortium
🇺🇸
South Bend, Indiana, United States
Cedar Rapids Oncology Associates
🇺🇸
Cedar Rapids, Iowa, United States
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CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States