Phase 2
N=134
Fruit and Vegetable Extracts in Treating Patients With Stage I-IV, Stage IVA/IVB Head and Neck Cancer
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00064298 ↗Enrolled (actual)
134
Serious AEs
3.2%
Results posted
Jul 2017
Primary outcome: Primary: Expression of p27 Cell Cycle Regulatory Protein at Baseline and Week 12 — 18.6; 15.1; 17.0; 14.5 percentage of cells
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- fruit and vegetable extracts (Dietary_supplement); placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Expression of p27 Cell Cycle Regulatory Protein at Baseline and Week 12 |
18.6; 15.1; 17.0; 14.5 | — |
| SECONDARY Cell Proliferation (Ki-67) at Baseline and Week 12 |
26.8; 26.2; 27.1; 27.0 | — |
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])
Data sourced from ClinicalTrials.gov (NCT00064298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.