Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III 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.

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: Randomizedphase II trial to study the effectiveness of fruit and vegetable extracts in preventing the recurrence of stage I, stage II, or stage III head and neck cancer. Condition:- Hypopharyngeal Cancer- Laryngeal Cancer- lip and oral cavity cancer- Oropharyngeal Cancer Study Type: InterventionalStudy Design: Treatment Official Title: Phase II Randomized Study of Fruit and Vegetable Extracts in Patients With Stage I-III Head and Neck CancerFurther Study Details: OBJECTIVES:Compare the disease-free survival of patients with stage I-III 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). 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 Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Criteria DISEASE CHARACTERISTICS:Curatively treated stage I-III 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: Age18 and over Performance statusKarnofsky 70-100% OR Zubrod 0-1 Life expectancyAt least 6 months HematopoieticHemoglobin greater than 10 g/dL WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 HepaticBilirubin no greater than 1.5 mg/dL SGOT less than 40 U/L SGPT no greater than 56 U/L RenalCreatinine no greater than 1.5 mg/dL OtherNo other concurrent malignancy No other serious medical or psychiatric illness that would preclude giving informed consent No nausea grade 2 or greater PRIOR CONCURRENT THERAPY: Biologic therapyNot specified ChemotherapySee Disease Characteristics More than 24 weeks since prior chemotherapy No concurrent chemotherapy No other concurrent chemopreventive agents Endocrine therapyMore than 24 weeks since prior hormonal therapy RadiotherapySee Disease Characteristics More than 24 weeks since prior radiotherapy No concurrent radiotherapy SurgerySee Disease Characteristics More than 24 weeks since prior surgery No concurrent surgery OtherMore than 6 months 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]) [1] Jennifer J. Hu, PhD, Study Chair, Comprehensive Cancer Center of Wake Forest University