Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, Stage III, Stage IVA, or Stage IVB Head and Neck Cancer

Basic Trial Information

Objectives

1. 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.
2. Compare the effect of these extracts on biomarkers (p27 expression, cell proliferation of Ki-67, DNA damage, and T-cell function) in these patients.
3. 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.
4. Compare serum carotenoids and antioxidant levels (vitamins A, C, and E) at baseline and posttreatment in patients treated with these extracts.

Entry 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

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])

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/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

A total of 200 patients (100 per treatment arm) will be accrued for this study within 18 months.

Outcomes

Expression of p27 cell cycle regulatory protein, associated with disease-free survival as measured by blood sample at baseline and week 12

Cell proliferation (Ki-67), DNA damage (strand breaks), and immune function (T-cell function) as measured by biopsy at baseline and week 12
Tobacco and alcohol use as measured by head and neck baseline questionnaire and food frequency questionnaire at baseline and week 12
Depression as measured by Center for Epidemiologic Depression scale and positive symptom subscale at baseline and week 12
Serum carotenoids and antioxidant levels (vitamins A, C, and E) as measured by blood tests at baseline and week 12

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.

Trial Contact Information

Trial Lead Organizations

Wake Forest University CCOP Research Base

Steven Akman, MD, Protocol chair		Ph: 336-716-0230; 800-446-2255 Email: sakman@wfubmc.edu

Registry Information
Official Title		A Phase II Randomized Placebo Controlled, Double Blinded Trial To Evaluate The Effects Of Fruit And Vegetable Extracts On Intermediate Biomarkers In Head And Neck Cancer Patients
Trial Start Date		2004-01-22
Trial Completion Date		2009-01-28
Registered in ClinicalTrials.gov		NCT00064298
Date Submitted to PDQ		2003-05-30
Information Last Verified		2008-10-14
NCI Grant/Contract Number		CA12197

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