Beta-carotene and Alpha-tocopherol Chemoprevention of Second Primary Malignancies in Head and Neck Cancer Patients
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Dietary Supplement: Alpha-Tocopherol and Beta-Carotene supplements Other: Placebo |
Phase 3 |
| Study Type: | 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 |
| Official Title: | Beta-carotene and Alpha-tocopherol Chemoprevention of Second Primary Malignancies in Head and Neck Cancer Patients |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: Baseline, at the end of radiation therapy (RT), 1, 6,12,24 and 36 months after RT ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]Without recurrence and without second primary cancer
- Overall survival [ Time Frame: Every year ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]Alive and without recurrence
- Survival until death from first cancer [ Time Frame: every year ] [ Designated as safety issue: No ]
- Survival until death from second primary cancer [ Time Frame: Every year ] [ Designated as safety issue: No ]
- Survival until death from non-cancer causes [ Time Frame: Every year ] [ Designated as safety issue: No ]
| Enrollment: | 540 |
| Study Start Date: | October 1994 |
| Primary Completion Date: | June 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Vitamin E |
Dietary Supplement: 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 |
Other: Placebo
Alpha-Tocopherol placebo and Beta-Carotene placebo (the Beta-Carotene placebo was stopped during the trial)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| Canada, Quebec | |
| Laval University Cancer Research Center | |
| Quebec City, Quebec, Canada, G1R 2J6 | |
| Principal Investigator: | Isabelle Bairati, MD, PhD | Laval University |
More Information
Publications:
| Responsible Party: | Isabelle Bairati, Professor (médecin), Laval University |
| ClinicalTrials.gov Identifier: | NCT00169845 History of Changes |
| Other Study ID Numbers: | 27370, NCIC-4738, NCIC-8176, NCIC-13211, NCIC-019502, 1R03CA141615-01, 018100 |
| Study First Received: | September 9, 2005 |
| Last Updated: | August 6, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Laval University:
|
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 |
Additional relevant MeSH terms:
|
Neoplasms Head and Neck Neoplasms Neoplasms, Second Primary Neoplasms by Site Carotenoids Alpha-Tocopherol Vitamin E Tocopherols Tocotrienols |
Beta Carotene Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 16, 2013