Fruit and Vegetable Extracts in Treating Patients With Stage I-IV, Stage IVA/IVB Head and Neck Cancer
Head and Neck Cancer
About this trial
This is an interventional prevention trial for Head and Neck Cancer focused on measuring 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
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])
Sites / Locations
- CCOP - Santa Rosa Memorial Hospital
- Redwood Regional Medical Group
- CCOP - Christiana Care Health Services
- MBCCOP - Howard University Cancer Center
- CCOP - Mount Sinai Medical Center
- University of Miami Sylvester Comprehensive Cancer Center - Miami
- MBCCOP - JHS Hospital of Cook County
- CCOP - Central Illinois
- CCOP - Northern Indiana CR Consortium
- Cedar Rapids Oncology Associates
- MBCCOP - LSU Health Sciences Center
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
- CCOP - Michigan Cancer Research Consortium
- CCOP - Beaumont
- CCOP - Metro-Minnesota
- Missouri Baptist Cancer Center
- CCOP - St. Louis-Cape Girardeau
- CCOP - Cancer Research for the Ozarks
- Alamance Cancer Center at Alamance Regional Medical Center
- Hugh Chatham Memorial Hospital
- CCOP - Southeast Cancer Control Consortium
- Leo W. Jenkins Cancer Center at ECU Medical School
- High Point Regional Hospital
- Caldwell Memorial Hospital
- Wake Forest University Comprehensive Cancer Center
- CCOP - Greenville
- CCOP - Upstate Carolina
- Danville Regional Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm I - JuicePlus
Arm II - Control
Patients receive oral fruit and vegetable extracts twice daily.
Patients receive oral placebo twice daily.