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.

Condition	Treatment or Intervention	Phase
Hypopharyngeal Cancer Laryngeal Cancer lip and oral cavity cancer Oropharyngeal Cancer	Drug: fruit and vegetable extracts  Procedure: biologically based therapies  Procedure: cancer prevention intervention  Procedure: chemoprevention of cancer  Procedure: complementary and alternative therapy  Procedure: herbal medicine / botanical therapy  Procedure: nutritional supplementation	Phase II

Further Study Details: 

OBJECTIVES:

• Compare the disease-free survival of patients with stage I-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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Curatively treated stage I-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 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])

Louisiana
      MBCCOP - LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1030,  United States; Recruiting

Study chairs or principal investigators

Steven Alan Akman, MD,  Study Chair,  Comprehensive Cancer Center of Wake Forest University   

Study ID Numbers:  CDR0000310184; CCCWFU-0112; CCCWFU-60A02; CCCWFU-BG03-161; NCT00064298
Record last reviewed:  January 2005
Last Updated:  February 7, 2005
Record first received:  July 8, 2003
ClinicalTrials.gov Identifier:  NCT00064298
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08