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Prevention of Capsular Contracture Using Trental and Vitamin E

NCT ID: NCT01082003

Last Updated: 2013-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Capsular Contractures

Keywords

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Capsular contractures in breast cancer patients

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Permanent Implant

Trental and Vitamin E for 6 months

Group Type OTHER

Trental

Intervention Type DRUG

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

Tissue Expander

Trental and Vitamin E for 6 months

Group Type OTHER

Trental

Intervention Type DRUG

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

Interventions

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Trental

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Legacy Health System

OTHER

Sponsor Role lead

Responsible Party

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Nathalie Johnson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nathalie Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

Legacy Health System

Locations

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Legacy Good Samaritan Medical Center

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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LHS T-E01

Identifier Type: -

Identifier Source: org_study_id