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Completed

NCT Number: NCT00169845

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Laval University Cancer Research Center

Québec, Quebec, G1R 2J6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alpha-Tocopherol and Beta-Carotene

Dietary Supplement

Provided by Roche Vitamins Inc.

Placebo

Dietary Supplement

Provided by Roche Vitamins Inc

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Quality of life

    Time frame: Baseline, at the end of radiation therapy (RT), 1, 6,12,24 and 36 months after RT

  3. 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

  4. 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

  5. Overall survival

    Time frame: Every year

  6. 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

  7. Survival until death from first cancer

    Time frame: every year

  8. Survival until death from second primary cancer

    Time frame: Every year

  9. Survival until death from non-cancer causes

    Time frame: Every year

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Canadian Cancer Trials Group
  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
1994
Primary completion
2003
Study completion
2018
First posted
Sep 15, 2005
Registry last updated
Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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