Prevention of Capsular Contracture Using Trental and Vitamin E

Capsular Contractures Clinical Trial

Official title:

A Single Center, Prospective Treatment Trial to Assess Prophylactic Use of Trental (Pentoxifylline) and Vitamin E to Prevent Capsular Contracture After Implant Reconstruction in Patients Requiring Adjuvant Radiation Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01082003
• Other study ID #: LHS T-E01
• Status: Active, not recruiting
• Phase: N/A
• First received: March 4, 2010
• Last updated: August 27, 2013
• Start date: October 2009
• Est. completion date: June 2014

Study information

• Verified date: August 2013
• Source: Legacy Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

This is a single center, 18-month study in which 30 women will receive Trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin E, 400 international units orally twice daily for six months. Subjects will begin the treatment regimen within four weeks after completion of radiation treatment and will remain on the study drugs for six months. Following completion of active treatment, all subjects will enter the twelve-month observational phase of the trial in which they will be evaluated for changes in breast tissue using the following objective tools: Bakers Grade Assessment, Visual Analog Scale (VAS), implant revision or loss, breast photographs, adverse event assessment and the Quality of Life tool (SF-12).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Capsular Contractures
• Contracture

Intervention

Drug:
• Trental
Trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin E, 400 international units orally twice daily for six months.

Locations

Country	Name	City	State
United States	Legacy Good Samaritan Medical Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Legacy Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure number and grade of contractures occurring after implant reconstruction and radiation treatment in subjects receiving Trental and vitamin E combination compared to placebo using the Bakers grade assessment		6 months	No
Secondary	Number of implant revisions or loss of implants due to post radiation changes in subject receiving Trental and vitamin E compared to placebo through patient interview with research staff		6 months	No