The Use of Pentoxifylline and Vitamin E in the Treatment of Chronic Breast Pain

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Study of the Use of Pentoxifylline and a-Tocopherol in the Treatment of Chronic Breast Pain Associated With Breast Radiotherapy

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: pentoxifylline
* Drug: alpha-Tocopherol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: UICC TNM stage 0 (i.e. in situ disease), 1 or 2 breast cancer patients treated with conservative surgery and adjuvant radiotherapy with chronic breast pain or tenderness, with or without fibrosis, within 3 months to 3 years following completion of radiotherapy Age 18 to 75 years of age Chronic symptoms localised to the breast treated with radiation, i.e. any one or more of the following- pain (not attributable to infection) or tenderness with or without associated oedema, fibrosis, necrosis or ulceration. Breast pain (maximum in the previous 24 hours) measurable on a Linear Analogue Scale with a length of 3cm or greater Prior treatment with radiation to the affected area i.e. in tangential breast fields or boost area Radiation completed at least 3 months and no longer than 3 years prior to study entry Informed consent Exclusion Criteria: Active cellulitis in the breast Active malignant disease Any medical illness or condition judged likely by the local investigator to preclude safe administration of protocol treatment Contraindication to treatment with pentoxifylline (i.e. previously exhibited intolerance to pentoxifylline or other xanthines such as caffeine, theophylline or theobromine; recent cerebral and/or retinal haemorrhage; ischaemic heart disease; hypotension Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pentoxifylline|nan|
|Drug: alpha-Tocopherol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |