Double-Blind, Placebo-Controlled, Randomised Trial Of Alpha-Tocopherol And Oxpentifylline In Patients With Radiation Fibrosis
N/A
N/A
Both
Breast Cancer, Lymphedema
Trial Information
Double-Blind, Placebo-Controlled, Randomised Trial Of Alpha-Tocopherol And Oxpentifylline In Patients With Radiation Fibrosis
OBJECTIVES: I. Determine the effects of vitamin E and pentoxifylline on lymphedema in
patients previously treated with radiotherapy for breast cancer. II. Compare the normal
tissue injury and quality of life in patients treated with this regimen vs placebo.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
randomized to one of two treatment arms. Arm I: Patients receive oral vitamin E and oral
pentoxifylline twice daily for 6 months. Arm II: Patients receive oral placebo twice daily
for 6 months. Quality of life is assessed at baseline and at 3, 6, 9, and 12 months.
Patients are followed at 6 and 12 months.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Prior diagnosis of breast cancer T1-3, N0-1, M0 Prior
radiotherapy to breast/chest wall plus axilla and/or supraclavicular fossa At least 2
years since prior radiotherapy No disease recurrence Arm lymphedema due to prior
radiotherapy Reduced shoulder movement, induration in breast/chest wall, radiation-induced
brachial plexopathy, symptomatic lung fibrosis, or non-healing wounds (including
fractures) allowed as evidence of disability in addition to arm lymphedema Hormone
receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Not specified Sex: Female or male Menopausal status: Not
specified Performance status: Not specified Life expectancy: Not specified Hematopoietic:
Not specified Hepatic: No liver failure Renal: No renal failure Cardiovascular: No
ischemic heart disease No hypertension No hypotension No acute myocardial infarction No
prior cerebral hemorrhage No prior retinal hemorrhage Other: Not pregnant Negative
pregnancy test Fertile patients must use effective contraception No allergy to coconut oil
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: No concurrent insulin Radiotherapy: See Disease Characteristics
Surgery: No prior axillary surgery Lower axillary sampling allowed Other: At least 3
months since prior daily vitamin E supplementation of more than 30 mg/day No prior
pentoxifylline after radiotherapy No concurrent ketorolac or vitamin K No other concurrent
vitamin E supplementation
Type of Study:
Interventional
Study Design:
Primary Purpose: Supportive Care
Principal Investigator
John R. Yarnold, MD, FRCR
Investigator Role:
Study Chair
Investigator Affiliation:
Royal Marsden NHS Foundation Trust
Authority:
United States: Federal Government
Study ID:
CDR0000068794
NCT ID:
NCT00022204
Start Date:
January 2000
Completion Date:
Related Keywords:
- Breast Cancer
- Lymphedema
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- lymphedema
- male breast cancer
- Breast Neoplasms
- Lymphedema
- Radiation Pneumonitis
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