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

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status and phase

Completed
Phase 2

Conditions

Head and Neck Cancer

Treatments

Dietary Supplement: fruit and vegetable extracts
Dietary Supplement: placebo

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])

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

134 participants in 2 patient groups, including a placebo group

Arm I - JuicePlus
Experimental group
Description:
Patients receive oral fruit and vegetable extracts twice daily.
Treatment:
Dietary Supplement: fruit and vegetable extracts
Arm II - Control
Placebo Comparator group
Description:
Patients receive oral placebo twice daily.
Treatment:
Dietary Supplement: placebo

Trial contacts and locations

28

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Data sourced from clinicaltrials.gov

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