Trental & Vitamin E for Radiation-Induced Fibrosis

Study Overview
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Brief Summary
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This study seeks to determine if a combination of Trental and Vitamin E prevents the development of radiation fibrosis in women treated with radiation for the definitive management of their breast cancer.

Detailed Description
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Radiation fibrosis occurs in approximately 25% of those women treated with radiation for breast cancer. Of these, approximately 3 to 5% will develop into an acute, painful form of fibrosis. Mild fibrosis can present as a thicker or more dense breast where the acute form can cause pain in the breast, significant hardening, and inflammation. Treatments for fibrosis are lacking, with the primary treatment being hyperbaric oxygen therapy. The combination of Trental & Vitamin E has been used with success in Europe and at the University of Iowa. The focus of this study is to prevent fibrosis through intervention with Trental & Vitamin E. The study has two arms, a control arm and an intervention arm. The study is not blinded. Measurements are taken at standard follow-up visits to measure breast density and lymphedema.

Official Title
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Development of Radiation Fibrosis in Patients Treated With Pentoxyphylline and Vitamin E: a Prospective Randomized Study

Conditions
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Fibrosis

Intervention / Treatment
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* Drug: Pentoxifylline
* Drug: Vitamin E


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically documented cancer of the breast or DCIS or head and neck referred for definitive radiation with curative intent. No evidence of metastatic disease. Minimum life expectancy of at least 12 months. Aged greater than 20 years. If female, pregnancy excluded. No documented history of collagen vascular disease. Exclusion Criteria: Cognitively impaired patients Prisoners No histology available Documented metastatic disease Allergy to Trental Life expectance of less than 12 months. Aged less than 20 years Collagen vascular disease present Pregnant History of liver disease Use of anticoagulants

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Control for study - watchful waiting. | |
| Experimental: 2<br>Combined treatment with Pentoxifylline and Vitamin E. | Drug: Pentoxifylline<br>* Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy.<br>* Other names: Trental;Drug: Vitamin E<br>* Vitamin E (Over-the-counter) 400 I.U. once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective, Objective, Management, and Analytic (SOMA) Score | A primary outcome of interest is the composite Subjective, Objective, Management, and Analytic (SOMA) score at 18-month follow-up visit. Maximum score is 45, with a score of 0 being ideal and representing no treatment-related side effects at the study visit. | 18 month post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue Compliance | Tissue compliance meter measurements of the treated breast compared to the non-treated breast were obtained at 18 months post-radiation therapy. Tissue compliance simply means how soft and pliable the breast tissue is when force is applied to it. One physician would hold the tissue compliance meter (TCM) against the participant's skin. A standard amount of force would be applied. A second physician would read the displacement scale for a specific set of areas on the breast. The range of the scale was 0 to 60 milimeters (mm). The physician's were blineded to the participant's intervention at the time of measurement. The final value is the difference between the untreated and the treated breast [untreated - treated]. The range of these differences was -3.3 to 7.0 mm. | 18 months post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Neoplasms, Radiotherapy