Prevention of Capsular Contracture Using Trental and Vitamin E

Status unconfirmed · Not applicable

Conditions studied: Capsular Contractures

In brief

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.

Key facts

Study ID

NCT01082003

Run by

Legacy Health System

People needed

30

Starts

2009-10-01

Expected to finish

2014-06-01

Last updated by the study team

2013-08-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• < 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

Where it is running

• Legacy Good Samaritan Medical Center — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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