Prevention of Capsular Contracture Using Trental and Vitamin E

NCT01082003 | Unknown DMC

• 1 other identifier: LHS T-E01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Capsular Contractures

Keywords

Capsular contractures in breast cancer patients

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

Permanent Implant

OTHER

Trental and Vitamin E for 6 months

Drug: Trental

Tissue Expander

OTHER

Trental and Vitamin E for 6 months

Drug: Trental

Interventions

Trental DRUG

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

Permanent Implant; Tissue Expander

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Legacy Health System: lead

Study Sites (1)

Legacy Good Samaritan Medical Center

Portland, Oregon, 97210, United States

Location

MeSH Terms

Interventions

Pentoxifylline

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nathalie Johnson, MD

  Legacy Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 5, 2010
• Study Start: October 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: June 1, 2014
• Last Updated: August 28, 2013

Record last verified: 2013-08

Locations

US (1)