Overview

This trial is active, not recruiting.

Condition neoplasms
Treatments alpha-tocopherol and beta-carotene supplements, placebo
Phase phase 3
Sponsor Laval University
Collaborator NCIC Clinical Trials Group
Start date October 1994
End date June 2003
Trial size 540 participants
Trial identifier NCT00169845, 018100, 1R03CA141615-01, 27370, NCIC-019502, NCIC-13211, NCIC-4738, NCIC-8176

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
alpha-tocopherol and beta-carotene supplements
Alpha-Tocopherol (400 IU/d during RT and 3 years) and Beta-Carotene: 30 mg/d (stopped during the trial)
(Placebo Comparator)
placebo
Alpha-Tocopherol placebo and Beta-Carotene placebo (the Beta-Carotene placebo was stopped during the trial)

Primary Outcomes

Measure
Second primary cancers
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

Secondary Outcomes

Measure
Acute and late side-effects of radiation therapy
time frame: During radiation therapy (RT), at the end of RT, one month after RT, six months after RT and 1 year after RT
Quality of life
time frame: Baseline, at the end of radiation therapy (RT), 1, 6,12,24 and 36 months after RT
Recurrence
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
Cancer free survival
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
Overall survival
time frame: Every year
Disease free survival
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
Survival until death from first cancer
time frame: every year
Survival until death from second primary cancer
time frame: Every year
Survival until death from non-cancer causes
time frame: Every year

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Beta-carotene and Alpha-tocopherol Chemoprevention of Second Primary Malignancies in Head and Neck Cancer Patients
Principal investigator Isabelle Bairati, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Laval University.