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Prevention of Capsular Contracture Using Trental and Vitamin E

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01082003
Recruitment Status : Unknown
Verified August 2013 by Nathalie Johnson, Legacy Health System.
Recruitment status was:  Active, not recruiting
First Posted : March 5, 2010
Last Update Posted : August 28, 2013
Sponsor:
Information provided by (Responsible Party):
Nathalie Johnson, Legacy Health System

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Capsular Contractures Drug: Trental Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2009
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01082003


Locations
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United States, Oregon
Legacy Good Samaritan Medical Center
Portland, Oregon, United States, 97210
Sponsors and Collaborators
Legacy Health System
Investigators
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Principal Investigator: Nathalie Johnson, MD Legacy Health System
More Information
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Responsible Party: Nathalie Johnson, Principal Investigator, Legacy Health System
ClinicalTrials.gov Identifier: NCT01082003    
Other Study ID Numbers: LHS T-E01
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013
Keywords provided by Nathalie Johnson, Legacy Health System:
Capsular contractures in breast cancer patients
Additional relevant MeSH terms:
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Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants