Beta-carotene and Alpha-tocopherol Chemoprevention of Second Primary Malignancies in Head and Neck Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Isabelle Bairati, Laval University
ClinicalTrials.gov Identifier:
NCT00169845
First received: September 9, 2005
Last updated: September 16, 2013
Last verified: September 2013
  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

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00169845

Locations
Canada, Quebec
Laval University Cancer Research Center
Quebec City, Quebec, Canada, G1R 2J6
Sponsors and Collaborators
Laval University
NCIC Clinical Trials Group
Investigators
Principal Investigator: Isabelle Bairati, MD, PhD Laval University
  More Information

Publications:

Responsible Party: Isabelle Bairati, Professor (MD, PhD), 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: September 16, 2013
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
Tocopherols
Vitamin E
Alpha-Tocopherol
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 April 23, 2014