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

This study is no longer recruiting patients.

Sponsored by: Royal Marsden NHS Trust
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
stage I breast cancer
Male Breast Cancer
stage IIIA breast cancer
stage II breast cancer
Quality of Life
Lymphedema
 Procedure: supportive care
 Procedure: complications of therapy assessment/management
 Behavior: supportive care/therapy
 Procedure: quality-of-life assessment
 Drug: pentoxifylline
 Drug: vitamin E
Phase II

MedlinePlus related topics:  Breast Cancer;   Lymphatic Diseases;   Male Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Educational/Counseling/Training

Official Title: Phase II Randomized Study of Vitamin E and Pentoxifylline in Patients With Lymphedema After Radiotherapy for Breast Cancer

Further Study Details: 

Study start: January 2000

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.

PROTOCOL 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.

Eligibility

Criteria

PROTOCOL 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--

--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

Location Information


United Kingdom, England
      Royal Marsden Hospital, Sutton,  England,  SM2 5PT,  United Kingdom

Study chairs or principal investigators

John Robert Yarnold,  Study Chair,  Royal Marsden NHS Trust   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068794; RM-1597; EU-20050
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  August 10, 2001
ClinicalTrials.gov Identifier:  NCT00022204
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005