Clinical Trial: The Use of Pentoxifylline and Vitamin E in the Treatment of Chronic Breast Pain
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase II Study of the Use of Pentoxifylline and a-Tocopherol in the Treatment of Chronic Breast Pain Associated With Breast Radiotherapy
Brief 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.
Detailed Summary:
Sponsor: University Health Network, Toronto
Current Primary Outcome:
- To assess improvement in breast pain with use of the interventional agents.
- To assess improvement in patient function with the use of the interventional agents.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To assess time to maximal improvement in pain, durability of response, quality of life changes during the study
- To qualitatively characterise presenting pain syndromes
- To examine techniques for objective assessment of breast edema and texture/fibrotic changes
- To investigate the feasibility of the use of high resolution (40MHz) ultrasound and whether changes can be measured
Original Secondary Outcome: Same as current
Information By: University Health Network, Toronto
Dates:
Date Received: September 12, 2005
Date Started: July 2002
Date Completion:
Last Updated: August 10, 2010
Last Verified: August 2010
