Prevention of Capsular Contracture Using Trental and Vitamin E
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Capsular Contractures |
Drug: Trental |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| 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 |
- 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 [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: No ]
| Estimated Enrollment: | 62 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Permanent Implant
Randomized to either Trental and Vitamin E or Placebo for 6 months
|
Drug: Trental
Trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin E, 400 international units orally twice daily or placebo for six months.
|
|
Tissue Expander
Randomized to either Trental and Vitamin E or Placebo for 6 months
|
Drug: Trental
Trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin E, 400 international units orally twice daily or placebo for six months.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Oregon | |
| Legacy Good Samaritan Medical Center | |
| Portland, Oregon, United States, 97210 | |
| Principal Investigator: | Nathalie Johnson, MD | Legacy Health System |
More Information
No publications provided
| Responsible Party: | Nathalie Johnson, MD, Prinicipal Investigator, Legacy Health System |
| ClinicalTrials.gov Identifier: | NCT01082003 History of Changes |
| Other Study ID Numbers: | LHS T-E01 |
| Study First Received: | March 4, 2010 |
| Last Updated: | February 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Legacy Health System:
|
Capsular contractures in breast cancer patients |
Additional relevant MeSH terms:
|
Contracture Joint Diseases Musculoskeletal Diseases Muscular Diseases Pentoxifylline Vitamin E Alpha-Tocopherol Tocopherols Tocotrienols Vitamins Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Radiation-Protective Agents Protective Agents Physiological Effects of Drugs Vasodilator Agents Cardiovascular Agents Free Radical Scavengers Antioxidants Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on June 18, 2013