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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

September 9, 2005
October 17, 2016
October 1994
June 2003   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Second primary cancers
Complete list of historical versions of study NCT00169845 on ClinicalTrials.gov Archive Site
  • 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: 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 ] [ Designated as safety issue: No ]
  • 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 ] [ 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: 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 ] [ 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 ]
  • Acute and late side-effects of radiation therapy
  • Quality of life
  • Recurrence
  • Cancer free survival
  • Overall survival
  • Disease specific survival
Not Provided
Not Provided
 
Beta-carotene and Alpha-tocopherol Chemoprevention of Second Primary Malignancies in Head and Neck Cancer Patients
Beta-carotene and Alpha-tocopherol Chemoprevention of Second Primary Malignancies in Head and Neck Cancer Patients

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Neoplasms
  • Dietary Supplement: Alpha-Tocopherol and Beta-Carotene
    Provided by Roche Vitamins Inc.
  • Dietary Supplement: Placebo
    Provided by Roche Vitamins Inc
  • 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.
    Intervention: Dietary Supplement: Alpha-Tocopherol and Beta-Carotene
  • 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.
    Intervention: Dietary Supplement: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
540
December 2020
June 2003   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00169845
27370, NCIC-4738, NCIC-8176, NCIC-13211, NCIC-019502, 1R03CA141615-01, 018100
Yes
Yes
A letter was sent to each participant.
Isabelle Bairati, Laval University
Laval University
  • Canadian Cancer Trials Group
  • National Cancer Institute (NCI)
Principal Investigator: Isabelle Bairati, MD, PhD Laval University
Laval University
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP