The Use of Pentoxifylline and Vitamin E in the Treatment of Chronic Breast Pain
NCT00188669 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2010-08-11
Summary
An estimated 20 - 45 % of women treated with breast conserving treatment experience chronic pain in the treated breast. The aetiology of this is poorly understood. Some of these women have signs of chronic radiation mastitis. There is no accepted treatment for this condition. The combination of pentoxifylline and vitamin E has been shown to be effective in reversing radiation fibrosis in this region. Many of these patients have had a benefit in pain response in a time period of a few benefits. This study is a phase II study of these drugs for a 6 month trial period to assess the effect on chronic breast pain in breast cancer patients who are 3 months to 3 years post radiation treatment.
Conditions
- Breast Neoplasms
Interventions
- DRUG
-
pentoxifylline
- DRUG
-
alpha-Tocopherol
Sponsors & Collaborators
-
Princess Margaret Hospital, Canada
collaborator OTHER -
University Health Network, Toronto
lead OTHER
Principal Investigators
-
Wilfred Levin, MD · Princess Margaret Hospital, Canada
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-07-31
Countries
- Canada
Study Locations
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