Beta-carotene and Alpha-tocopherol Chemoprevention of Second Primary Malignancies in Head and Neck Cancer Patients
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Laval University
- Enrollment
- 540
- Locations
- 2
- Primary Endpoint
- Second primary cancers
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Second primary cancers
Time Frame: 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 Outcomes
- 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)
- Survival until death from first cancer(every year)
- Survival until death from second primary 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)
- 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)
- Survival until death from non-cancer causes(Every year)
Investigators
Isabelle Bairati
Professor (MD, PhD)
Laval University