Clinical trial · Interventional
Prevention of Capsular Contracture Using Trental and Vitamin E
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Capsular Contractures | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trental | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Permanent Implant
- description
- Trental and Vitamin E for 6 months
- interventionNames
- Drug: Trental
- type
- OTHER
- label
- Tissue Expander
- description
- Trental and Vitamin E for 6 months
- interventionNames
- Drug: Trental
Primary outcomes (1)
- 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
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available