Beta-carotene and Alpha-tocopherol Chemoprevention of Second Primary Malignancies in Head and Neck Cancer Patients
- Conditions
- Neoplasms
- Registration Number
- NCT00169845
- Lead Sponsor
- Laval University
- Brief Summary
Epidemiologic studies suggest that low dietary intakes and low plasma concentrations of antioxidant vitamins and minerals are associated with increased risks of cancer, especially for epidermoid tumors. Patients with stage I or II head and neck cancer have a good prognosis, with a 5-year relative survival of 60% to 90%, depending of the tumor site. However, the benefit of treatment is often compromised by the occurrence of second primary cancers, which develop in 20% of patients during the first 5 years after diagnosis. We conducted a randomized chemoprevention trial among patients with head and neck cancer treated by radiation therapy to determine whether supplementation combining two antioxidants, alpha-tocopherol and beta-carotene, could reduce the incidence of second primary cancers in this patient population (primary objective of the trial). This study was conducted with funds from the NCIC (#008176,004738,013211) and was completed.
In this cohort of head and neck cancer patients, we evaluated whether nine potential prognostic serum markers measured at the time of diagnosis were related to recurrence, occurence of second primary cancers and survival. This study was conducted with funds from the NCIC (#018100) and was completed.
Presently, we evaluate genetic polymorphisms(GWAS) associated with prognosis (NCIC grant #019502). We also assess the relationship between vitamin D (dietary intake, serum level, and genetic polymorphisms of key vitamin D-related genes) and head and neck long-term outcomes (NCI grant #1R03CA141615-01).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 540
- Histologically documented stage I or II head and neck cancer
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Second primary cancers Immediately 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
- Secondary Outcome Measures
Name Time Method Survival until death from second primary cancer Every year Survival until death from non-cancer causes Every year Acute and late side-effects of radiation therapy During radiation therapy (RT), at the end of RT, one month after RT, six months after RT and 1 year after RT Overall survival Every year Disease free survival Immediately 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 Alive and without recurrence
Survival until death from first cancer every year Quality of life Baseline, at the end of radiation therapy (RT), 1, 6,12,24 and 36 months after RT Cancer free survival Immediately 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 Without recurrence and without second primary cancer
Recurrence Immediately 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
Trial Locations
- Locations (1)
Laval University Cancer Research Center
🇨🇦Quebec City, Quebec, Canada
Laval University Cancer Research Center🇨🇦Quebec City, Quebec, Canada