Prevention of Capsular Contracture Using Trental and Vitamin E
Information source: Legacy Health System
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Capsular Contractures
Intervention: Trental (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Legacy Health System Official(s) and/or principal investigator(s):
Nathalie Johnson, MD, Principal Investigator, Affiliation: Legacy Health System
Overall contact:
Legacy Oncology Clinical Research Legacy Oncology Research, Phone: 503-413-8199
Summary
The main purpose of this research study is to determine if the use of Trental and Vitamin E
compared to Placebo (an inactive substance) 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 compared to Placebo may 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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: 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: 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
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Legacy Oncology Clinical Research Legacy Oncology Research, Phone: 503-413-8199
Legacy Good Samaritan Medical Center, Portland, Oregon 97210, United States; Recruiting
Jeremy Douglas, BS, Phone: 503-413-8199
Nathalie Johnson, MD, Principal Investigator
Additional Information
Starting date: October 2009
Last updated: June 30, 2011
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