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Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer
This study is ongoing, but not recruiting participants.
Study NCT00022204   Information provided by National Cancer Institute (NCI)
First Received: August 10, 2001   Last Updated: August 19, 2009   History of Changes

August 10, 2001
August 19, 2009
January 2000
 
 
 
Complete list of historical versions of study NCT00022204 on ClinicalTrials.gov Archive Site
 
 
 
Vitamin E and Pentoxifylline in Treating Women With Lymphedema After Radiation Therapy for Breast Cancer
Double-Blind, Placebo-Controlled, Randomised Trial Of Alpha-Tocopherol And Oxpentifylline In Patients With Radiation Fibrosis

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.

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.

Phase II
Interventional
Supportive Care
  • Breast Cancer
  • Lymphedema
  • Dietary Supplement: vitamin E
  • Drug: pentoxifylline
  • Procedure: quality-of-life assessment
 
Gothard L, Cornes P, Earl J, Hall E, MacLaren J, Mortimer P, Peacock J, Peckitt C, Woods M, Yarnold J. 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. 2004 Nov;73(2):133-9.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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

Both
 
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00022204
 
CDR0000068794, RM-1597, EU-20050
Royal Marsden - Surrey
 
Study Chair: John R. Yarnold, MD, FRCR Royal Marsden - Surrey
National Cancer Institute (NCI)
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP