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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:
Canadian Cancer Trials Group
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Isabelle Bairati, Laval University
ClinicalTrials.gov Identifier:
NCT00169845
First received: September 9, 2005
Last updated: October 17, 2016
Last verified: October 2016
  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 Dietary Supplement: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Isabelle Bairati, Laval University:

Primary Outcome Measures:
  • 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 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 ]
  • 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 ]

Enrollment: 540
Study Start Date: October 1994
Estimated Study Completion Date: December 2020
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Canadian Cancer Trials Group
National Cancer Institute (NCI)
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 ( Other Grant/Funding Number: National Cancer Institute of Canada )
NCIC-8176 ( Other Grant/Funding Number: National Cancer Institute of Canada )
NCIC-13211 ( Other Grant/Funding Number: National Cancer Institute of Canada )
NCIC-019502 ( Other Grant/Funding Number: National Cancer Institute of Canada )
1R03CA141615-01 ( U.S. NIH Grant/Contract )
018100 ( Other Grant/Funding Number: National Cancer Institute of Canada )
Study First Received: September 9, 2005
Last Updated: October 17, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A letter was sent to each participant.

Keywords provided by Isabelle Bairati, 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:
Head and Neck Neoplasms
Neoplasms, Second Primary
Neoplasms by Site
Neoplasms
Tocopherols
Vitamin E
Tocotrienols
alpha-Tocopherol
Carotenoids
Beta Carotene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 17, 2017