Overview

Prevention of Capsular Contracture Using Trental and Vitamin E

Status:
Unknown status
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
Female
Summary
The main purpose of this research study is to determine if the use of Trental and Vitamin E 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 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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Legacy Health System
Treatments:
alpha-Tocopherol
Pentoxifylline
Tocopherols
Tocotrienols
Vitamin E
Vitamins
Criteria
Inclusion Criteria:

- Female subjects

- > 18 years of age

- Expected survival at least > 6 months

- Undergone mastectomy with expander or implant reconstruction > 3 weeks before
radiation therapy

- Completed chest wall irradiation in the past two weeks

- Willing to stop herbal medications as directed by physician

- Willing to stop daily use of supplemental vitamin E (Multivitamin with vitamin E
component is acceptable)

- Willing to travel to a Legacy Health System facility

- Agree to attend study visits outside of standard of care visits

- Normal PT-INR for subjects taking Coumadin

Exclusion Criteria:

- < 18 years of age

- Pregnant or lactating

- Have final implant placed < 3 weeks before start of radiation therapy

- Have evidence of ongoing infection or implant exposure before start of radiation
therapy

- Radiation completed more than 16 days prior to study start

- Retinitis Pigmentosa

- Unable to comply with protocol

- Unable to provide written informed consent

- Unwilling or unable to stop supplemental vitamin E

- PT-INR outside of acceptable range for subjects taking Coumadin

- Investigator does not believe study participation, for any reason is in the best
interest of the patient