Single Center, Randomized, Double-Blind Treatment Trial to Assess Prophylactic Use of Trental (Pentoxifylline) and Vitamin E Compared to Placebo in the Prevention of Capsular Contracture After Implant Reconstruction in Patients Requiring Adjuvant Radiation Therapy
18 Years
N/A
Female
Capsular Contractures
Trial Information
Single Center, Randomized, Double-Blind Treatment Trial to Assess Prophylactic Use of Trental (Pentoxifylline) and Vitamin E Compared to Placebo in the Prevention of Capsular Contracture After Implant Reconstruction in Patients Requiring Adjuvant Radiation Therapy
This is a single center trial conducted through Legacy Health System. Sixty-two patients
from Legacy Good Samaritan Hospital in Portland, Oregon will be enrolled. Study subjects
will be "randomized", like the flip of a coin, into one of the two study groups to receive
either Trental and Vitamin E or Placebo for a six-month period. You will be required to have
a total of 6 study visits at Legacy Good Samaritan Hospital. Your participation in this
study will begin within 2 weeks of completing radiation treatment and last a total of 18
months. You will continue to receive the standard treatment for your breast cancer while on
this study
Visual and clinical assessment of your chest area to include photographs is required in
order to meet the primary goal of the study.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Outcome Measure:
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
Safety Issue:
No
Principal Investigator
Nathalie Johnson, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Legacy Health System
Authority:
United States: Institutional Review Board
Study ID:
LHS T-E01
NCT ID:
NCT01082003
Start Date:
October 2009
Completion Date:
June 2013
Related Keywords:
- Capsular Contractures
- Capsular contractures in breast cancer patients
- Contracture
Name | Location |
|---|---|
| Legacy Good Samaritan Medical Center | Portland, Oregon 97210 |
