Fruit and Vegetable Extracts in Treating Patients With Stage I-IV, Stage IVA/IVB Head and Neck Cancer
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.
|Head and Neck Cancer||Dietary Supplement: fruit and vegetable extracts Dietary Supplement: placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase II Randomized Placebo Controlled, Double Blinded Trial To Evaluate The Effects Of Fruit And Vegetable Extracts On Intermediate Biomarkers In Head And Neck Cancer Patients|
- Expression of p27 cell cycle regulatory protein, associated with disease-free survival as measured by blood sample at baseline and week 12 [ Time Frame: baseline and 12 weeks ]
- Cell proliferation (Ki-67), DNA damage (strand breaks), and immune function (T-cell function) as measured by biopsy at baseline and week 12 [ Time Frame: baseline and 12 weeks ]
- Tobacco and alcohol use as measured by head and neck baseline questionnaire and food frequency questionnaire at baseline and week 12 [ Time Frame: baseline and 12 weeks ]
- Depression as measured by Center for Epidemiologic Depression scale and positive symptom subscale at baseline and week 12 [ Time Frame: baseline and 12 weeks ]
- Serum carotenoids and antioxidant levels (vitamins A, C, and E) as measured by blood tests at baseline and week 12 [ Time Frame: baseline and 12 weeks ]
|Study Start Date:||January 2004|
|Study Completion Date:||April 2009|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral fruit and vegetable extracts twice daily.
Dietary Supplement: fruit and vegetable extracts
Placebo Comparator: Arm II
Patients receive oral placebo twice daily.
Dietary Supplement: placebo
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00064298
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|Study Chair:||Steven A. Akman, MD||Wake Forest University Health Sciences|