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Prevention of Capsular Contracture Using Trental and Vitamin E

Primary Purpose

Capsular Contractures

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trental
Sponsored by
Legacy Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Capsular Contractures focused on measuring Capsular contractures in breast cancer patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Legacy Good Samaritan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Permanent Implant

Tissue Expander

Arm Description

Trental and Vitamin E for 6 months

Trental and Vitamin E for 6 months

Outcomes

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

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

Full Information

First Posted
March 4, 2010
Last Updated
August 27, 2013
Sponsor
Legacy Health System
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1. Study Identification

Unique Protocol Identification Number
NCT01082003
Brief Title
Prevention of Capsular Contracture Using Trental and Vitamin E
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 Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Legacy Health System

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Capsular Contractures
Keywords
Capsular contractures in breast cancer patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Permanent Implant
Arm Type
Other
Arm Description
Trental and Vitamin E for 6 months
Arm Title
Tissue Expander
Arm Type
Other
Arm Description
Trental and Vitamin E for 6 months
Intervention Type
Drug
Intervention Name(s)
Trental
Intervention Description
Trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin E, 400 international units orally twice daily for six months.
Primary Outcome Measure Information:
Title
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Johnson, MD
Organizational Affiliation
Legacy Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Legacy Good Samaritan Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States

12. IPD Sharing Statement

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Prevention of Capsular Contracture Using Trental and Vitamin E

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