Trental & Vitamin E for Radiation-Induced Fibrosis
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Development of Radiation Fibrosis in Patients Treated With Pentoxyphylline and Vitamin E: a Prospective Randomized Study|
- Subjective, Objective, Management, and Analytic (SOMA) Score [ Time Frame: 18 month post-treatment ]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.
- Tissue Compliance [ Time Frame: 18 months post-treatment ]
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.
|Study Start Date:||February 2003|
|Study Completion Date:||June 2012|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
No Intervention: 1
Control for study - watchful waiting.
Combined treatment with Pentoxifylline and Vitamin E.
Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy.
Other Name: TrentalDrug: Vitamin E
Vitamin E (Over-the-counter) 400 I.U. once daily
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583700
|United States, Iowa|
|The University of Iowa Hospitals & Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Geraldine Jacobson, MD MPH||department of radiation oncology|