fruit and vegetable extracts in treating patients with stage i-iv, stage iva/ivb head and neck cancer

Conditions: Head and Neck Cancer

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.

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.

Eligibility criteria:
disease characteristics: * curatively treated stage i-iv (including stage iva and ivb) squamous cell carcinoma of the upper aerodigestive tract of 1 of the following primary sites: * oral cavity * oropharynx * hypopharynx * larynx * disease-free for at least 6 months and no more than 3 years after completion of surgery, radiotherapy, and/or chemotherapy * no synchronous tumors patient characteristics: age * 18 and over performance status * karnofsky 70-100% or * zubrod 0-1 life expectancy * at least 6 months hematopoietic * hemoglobin ≥ 10 g/dl * wbc ≥ 3,000/mm\^3 * platelet count ≥ 100,000/mm\^3 hepatic * bilirubin ≤ 1.5 mg/dl * sgot ≤ 40 u/l * sgpt ≤ 56 u/l renal * creatinine ≤ 1.5 mg/dl other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no other malignancy within the past 5 years except curatively treated head and neck squamous cell carcinoma, nonmelanoma skin cancer, or carcinoma in situ of the cervix * no other serious medical or psychiatric illness that would preclude giving informed consent * no nausea ≥ grade 2 prior concurrent therapy: biologic therapy * not specified chemotherapy * see disease characteristics * more than 6 months and less than 3 years since prior chemotherapy * no concurrent chemotherapy * no other concurrent chemopreventive agents endocrine therapy * more than 6 months and less than 3 years since prior hormonal therapy radiotherapy * see disease characteristics * more than 6 months and less than 3 years since prior radiotherapy * no concurrent radiotherapy surgery * see disease characteristics * more than 6 months and less than 3 years since prior surgery * no concurrent surgery other * more than 6 months and less than 3 years since prior investigational agents * more than 2 months since prior high-dose vitamins (i.e., 10 times the recommended daily allowance \[8,000-10,000 iu of vitamin a, 600 mg of vitamin c, or 80-100 iu of vitamin e\])

Keywords: stage i squamous cell carcinoma of the hypopharynx stage i squamous cell carcinoma of the larynx stage i squamous cell carcinoma of the lip and oral cavity stage i squamous cell carcinoma of the oropharynx stage ii squamous cell carcinoma of the hypopharynx stage ii squamous cell carcinoma of the larynx stage ii squamous cell carcinoma of the lip and oral cavity stage ii squamous cell carcinoma of the oropharynx stage iii squamous cell carcinoma of the hypopharynx stage iii squamous cell carcinoma of the larynx stage iii squamous cell carcinoma of the lip and oral cavity stage iii squamous cell carcinoma of the oropharynx stage iv squamous cell carcinoma of the hypopharynx stage iv squamous cell carcinoma of the larynx stage iv squamous cell carcinoma of the lip and oral cavity stage iv squamous cell carcinoma of the oropharynx