Overview

Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Vitamin E and pentoxifylline may be effective in decreasing lymphedema in women who have received radiation therapy for breast cancer. PURPOSE: Randomized phase II trial to determine the effectiveness of combining vitamin E and pentoxifylline in treating women who have lymphedema after receiving radiation therapy for breast cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Treatments:
alpha-Tocopherol
Pentoxifylline
Tocopherols
Tocotrienols
Vitamin E
Vitamins
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