Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care Closed Not specified Other RM-1597 EU-20050, NCT00022204

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.

Entry 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

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
 

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

Expected Enrollment

A total of 100 patients (50 per treatment arm) will be accrued for this study.

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.

Gothard L, Cornes P, Earl J, et al.: Double-blind placebo-controlled randomised trial of vitamin E and pentoxifylline in patients with chronic arm lymphoedema and fibrosis after surgery and radiotherapy for breast cancer. Radiother Oncol 73 (2): 133-9, 2004.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Royal Marsden - Surrey

John Yarnold, MD, FRCR, Protocol chair		Ph: 44-20-8661-3388

Registry Information
Official Title		Double-Blind, Placebo-Controlled, Randomised Trial Of Alpha-Tocopherol And Oxpentifylline In Patients With Radiation Fibrosis
Trial Start Date		2000-01-01
Registered in ClinicalTrials.gov		NCT00022204
Date Submitted to PDQ		2001-06-08
Information Last Verified		2007-05-07