Fruit and Vegetable Extracts in Treating Patients With Stage I-IV, Stage IVA/IVB Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: fruit and vegetable extracts; placebo
Intervention description: Given orally; Given orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 134.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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.
    

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])