Prevention of Capsular Contracture Using Trental and Vitamin E

Sponsor

Legacy Health System (Other)

Overall Status

Unknown status

CT.gov ID

NCT01082003

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Capsular Contractures	Drug: Trental	N/A

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Study Start Date :

Oct 1, 2009

Anticipated Primary Completion Date :

Aug 1, 2013

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Permanent Implant Trental and Vitamin E for 6 months	Drug: Trental Trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin E, 400 international units orally twice daily for six months.
Other: Tissue Expander Trental and Vitamin E for 6 months	Drug: Trental Trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin E, 400 international units orally twice daily for six months.

Arm

Intervention/Treatment

Other: Permanent Implant

Trental and Vitamin E for 6 months

Drug: Trental

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

Other: Tissue Expander

Trental and Vitamin E for 6 months

Drug: Trental

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Legacy Good Samaritan Medical Center	Portland	Oregon	United States	97210

Sponsors and Collaborators

Legacy Health System

Investigators

Principal Investigator: Nathalie Johnson, MD, Legacy Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nathalie Johnson, Principal Investigator, Legacy Health System

ClinicalTrials.gov Identifier:

NCT01082003

Other Study ID Numbers:

LHS T-E01

First Posted:

Mar 5, 2010

Last Update Posted:

Aug 28, 2013

Last Verified:

Aug 1, 2013

Keywords provided by Nathalie Johnson, Principal Investigator, Legacy Health System

Capsular contractures in breast cancer patients

Additional relevant MeSH terms:

Contracture

Pentoxifylline

Study Results

No Results Posted as of Aug 28, 2013