Fruit and Vegetable Extracts in Treating Patients With Stage I-IV, Stage IVA/IVB Head and Neck Cancer

Wake Forest University (WFU)

Status and phase

Completed

Phase 2

Conditions

Head and Neck Cancer

Treatments

Dietary Supplement: placebo

Dietary Supplement: fruit and vegetable extracts

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00064298

U10CA081851 (U.S. NIH Grant/Contract)

REBAWFU-60A02

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

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.
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.

Enrollment

134 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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])