Beta-carotene and Alpha-tocopherol Chemoprevention of Second Primary Malignancies in Head and Neck Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00169845|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : March 14, 2018
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 or disease||Intervention/treatment||Phase|
|Neoplasms||Dietary Supplement: Alpha-Tocopherol and Beta-Carotene Dietary Supplement: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||540 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Beta-carotene and Alpha-tocopherol Chemoprevention of Second Primary Malignancies in Head and Neck Cancer Patients|
|Study Start Date :||October 1994|
|Actual Primary Completion Date :||June 2003|
|Actual Study Completion Date :||March 2018|
Experimental: Alpha-Tocopherol and Beta-Carotene
Patients received a daily supplementation of alpha-tocopherol (one capsule of 400 IU dl-alpha-tocopherol) and beta-carotene (one capsule of 30 mg) for 3 years after the end of radiation therapy. Due to ethical concerns, the beta-carotene supplementation was stopped during the trial (after the randomization of 156 patients). See details in JNCI, 2005: 97 (7), 481-8.
Dietary Supplement: Alpha-Tocopherol and Beta-Carotene
Provided by Roche Vitamins Inc.
Placebo Comparator: Placebo
Patients received two capsules of placebos per day during 3 years. When the beta-carotene was stopped, they received only one capsule.
Dietary Supplement: Placebo
Provided by Roche Vitamins Inc
- 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 ]
- 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: 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 ]
- Cancer free survival [ 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 ]Without recurrence and without second primary cancer
- Overall survival [ Time Frame: Every year ]
- Disease free survival [ 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 ]Alive and without recurrence
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169845
|Laval University Cancer Research Center|
|Quebec City, Quebec, Canada, G1R 2J6|
|Principal Investigator:||Isabelle Bairati, MD, PhD||Laval University|