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The main purpose of this research study is to determine if the use of Trental and Vitamin E compared to Placebo (an inactive substance) will decrease the incidence and severity of contractures (shrinking and or hardening of tissue surrounding the implant) associated with breast implant reconstruction following radiation treatment. Another goal is to find out the impact that Trental and Vitamin E compared to Placebo may have on implant loss or need for surgical intervention in the setting of chest wall radiation after reconstruction. In addition, the investigators want to evaluate the patient's sense of well being and quality of life.
This is a single center trial conducted through Legacy Health System. Sixty-two patients from Legacy Good Samaritan Hospital in Portland, Oregon will be enrolled. Study subjects will be "randomized", like the flip of a coin, into one of the two study groups to receive either Trental and Vitamin E or Placebo for a six-month period. You will be required to have a total of 6 study visits at Legacy Good Samaritan Hospital. Your participation in this study will begin within 2 weeks of completing radiation treatment and last a total of 18 months. You will continue to receive the standard treatment for your breast cancer while on this study
Visual and clinical assessment of your chest area to include photographs is required in order to meet the primary goal of the study.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Legacy Good Samaritan Medical Center
Legacy Health System
Published on BioPortfolio: 2014-08-26T22:15:24-0400
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