Prevention of Capsular Contracture Using Trental and Vitamin E
| Status: | Archived |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | October 2009 |
Single Center, Randomized, Double-Blind Treatment Trial to Assess Prophylactic Use of Trental (Pentoxifylline) and Vitamin E Compared to Placebo in the Prevention of Capsular Contracture After Implant Reconstruction in Patients Requiring Adjuvant Radiation Therapy
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.
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