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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Princess Margaret Hospital
Toronto, Ontario, Canada
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.
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
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