Prevention of Capsular Contracture Using Trental and Vitamin E

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nathalie Johnson, Legacy Health System
ClinicalTrials.gov Identifier:
NCT01082003
First received: March 4, 2010
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Capsular Contractures
Drug: Trental

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Legacy Health System:

Primary Outcome Measures:
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Permanent Implant
Trental and Vitamin E for 6 months
Drug: Trental
Trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin E, 400 international units orally twice daily for six months.
Tissue Expander
Trental and Vitamin E for 6 months
Drug: Trental
Trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin E, 400 international units orally twice daily for six months.

Detailed Description:

This is a single center, 18-month study in which 30 women will receive Trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin E, 400 international units orally twice daily for six months. Subjects will begin the treatment regimen within four weeks after completion of radiation treatment and will remain on the study drugs for six months. Following completion of active treatment, all subjects will enter the twelve-month observational phase of the trial in which they will be evaluated for changes in breast tissue using the following objective tools: Bakers Grade Assessment, Visual Analog Scale (VAS), implant revision or loss, breast photographs, adverse event assessment and the Quality of Life tool (SF-12).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082003

Locations
United States, Oregon
Legacy Good Samaritan Medical Center
Portland, Oregon, United States, 97210
Sponsors and Collaborators
Legacy Health System
Investigators
Principal Investigator: Nathalie Johnson, MD Legacy Health System
  More Information

No publications provided

Responsible Party: Nathalie Johnson, Principal 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: August 27, 2013
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
Muscular Diseases
Musculoskeletal Diseases
Alpha-Tocopherol
Pentoxifylline
Tocopherols
Tocotrienols
Vitamin E
Vitamins
Antioxidants
Cardiovascular Agents
Enzyme Inhibitors
Free Radical Scavengers
Growth Substances
Hematologic Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Radiation-Protective Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014