Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Neoplasms

Thank you

Trial Information

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


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.

Type of Study:

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

Outcome Measure:

Second primary cancers

Outcome 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

Safety Issue:

No

Principal Investigator

Isabelle Bairati, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Laval University

Authority:

Canada: Health Canada

Study ID:

27370

NCT ID:

NCT00169845

Start Date:

October 1994

Completion Date:

Related Keywords:

  • Neoplasms
  • 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
  • Neoplasms
  • Head and Neck Neoplasms
  • Neoplasms, Second Primary

Name

Location