Trial Information
Beta-carotene and Alpha-tocopherol Chemoprevention of Second Primary Malignancies in Head and Neck Cancer Patients
Inclusion Criteria:
- Histologically documented stage I or II head and neck cancer
Exclusion Criteria:
- Karnofsky performance score of less than 60
- Multiple primary head and neck cancer
- History of cancer
- Severe cardiovascular disease
- Inadequate renal, hepatic or hematologic function
- Anticoagulant therapy
- Pregnancy
- Average daily supplement intake of beta-carotene or vitamin E in the preceding year
greater than 6.0 mg and 50 IU, respectively.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Second primary cancers
Outcome Time Frame:
Immediatly and 1 month after radiation therapy, every 6 months during the 3 years following the end of radiation therapy, and then once a year until June 30, 2003
Safety Issue:
No
Principal Investigator
Isabelle Bairati, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Laval University
Authority:
Canada: Health Canada
Study ID:
27370
NCT ID:
NCT00169845
Start Date:
October 1994
Completion Date:
Related Keywords:
- Neoplasms
- chemoprevention trial
- antioxidant
- alpha-tocopherol
- beta-carotene
- second primary cancer
- head and neck cancer
- adverse effect of radiation therapy
- quality of life
- mortality
- cancer free survival
- cancer recurrence
- Neoplasms
- Head and Neck Neoplasms
- Neoplasms, Second Primary