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Prevention of Capsular Contracture Using Trental and Vitamin E

N/A
Waitlist Available
Led By Nathalie Johnson, MD
Research Sponsored by Legacy Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

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.

Eligible Conditions
  • Capsular Contracture

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2017 Phase 2 trial • 31 Patients • NCT01508221
10%
Fatigue
10%
Anxiety
6%
Anorexia
6%
Cough
6%
Nausea
3%
Diaphoresis
3%
Non-cardiac chest pain
3%
Vomiting
3%
Generalized weakness
3%
Leg swelling
3%
Back pain
3%
Lower back pain
3%
Orthostatic dizziness
3%
Right leg weakness
3%
Sleep disturbance
3%
Depression
3%
Pain in shoulder
3%
Weight loss
3%
Constipation
3%
Gait disturbance
3%
Arrhythmia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trental + Vitamin E

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Tissue ExpanderExperimental Treatment1 Intervention
Trental and Vitamin E for 6 months
Group II: Permanent ImplantExperimental Treatment1 Intervention
Trental and Vitamin E for 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pentoxifylline
FDA approved

Find a Location

Who is running the clinical trial?

Legacy Health SystemLead Sponsor
35 Previous Clinical Trials
3,651 Total Patients Enrolled
Nathalie Johnson, MDPrincipal InvestigatorLegacy Health System
3 Previous Clinical Trials
65 Total Patients Enrolled
~2 spots leftby Jan 2026
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