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Trental & Vitamin E for Radiation-Induced Fibrosis

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: NCT00583700
Recruitment Status : Completed
First Posted : December 31, 2007
Results First Posted : January 29, 2013
Last Update Posted : January 29, 2013
Sponsor:
Information provided by (Responsible Party):
University of Iowa

Tracking Information
First Submitted Date  ICMJE December 20, 2007
First Posted Date  ICMJE December 31, 2007
Results First Submitted Date  ICMJE October 18, 2012
Results First Posted Date  ICMJE January 29, 2013
Last Update Posted Date January 29, 2013
Study Start Date  ICMJE February 2003
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
Subjective, Objective, Management, and Analytic (SOMA) Score [ Time Frame: 18 month post-treatment ]
A primary outcome of interest is the composite Subjective, Objective, Management, and Analytic (SOMA) score at 18-month follow-up visit. Maximum score is 45, with a score of 0 being ideal and representing no treatment-related side effects at the study visit.
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
The primary outcome of interest is composite SOMA score at 18-month follow-up visit [ Time Frame: 18 month post-treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
Tissue Compliance [ Time Frame: 18 months post-treatment ]
Tissue compliance meter measurements of the treated breast compared to the non-treated breast were obtained at 18 months post-radiation therapy. Tissue compliance simply means how soft and pliable the breast tissue is when force is applied to it. One physician would hold the tissue compliance meter (TCM) against the participant's skin. A standard amount of force would be applied. A second physician would read the displacement scale for a specific set of areas on the breast. The range of the scale was 0 to 60 milimeters (mm). The physician's were blineded to the participant's intervention at the time of measurement. The final value is the difference between the untreated and the treated breast [untreated - treated]. The range of these differences was -3.3 to 7.0 mm.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
Tissue compliance of the treated breast compared to the non-treated breast [ Time Frame: 12 and 18 months post-treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trental & Vitamin E for Radiation-Induced Fibrosis
Official Title  ICMJE Development of Radiation Fibrosis in Patients Treated With Pentoxyphylline and Vitamin E: a Prospective Randomized Study
Brief Summary This study seeks to determine if a combination of Trental and Vitamin E prevents the development of radiation fibrosis in women treated with radiation for the definitive management of their breast cancer.
Detailed Description

Radiation fibrosis occurs in approximately 25% of those women treated with radiation for breast cancer. Of these, approximately 3 to 5% will develop into an acute, painful form of fibrosis. Mild fibrosis can present as a thicker or more dense breast where the acute form can cause pain in the breast, significant hardening, and inflammation.

Treatments for fibrosis are lacking, with the primary treatment being hyperbaric oxygen therapy. The combination of Trental & Vitamin E has been used with success in Europe and at the University of Iowa.

The focus of this study is to prevent fibrosis through intervention with Trental & Vitamin E. The study has two arms, a control arm and an intervention arm. The study is not blinded. Measurements are taken at standard follow-up visits to measure breast density and lymphedema.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Fibrosis
Intervention  ICMJE
  • Drug: Pentoxifylline
    Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy.
    Other Name: Trental
  • Drug: Vitamin E
    Vitamin E (Over-the-counter) 400 I.U. once daily
Study Arms  ICMJE
  • No Intervention: 1
    Control for study - watchful waiting.
  • Experimental: 2
    Combined treatment with Pentoxifylline and Vitamin E.
    Interventions:
    • Drug: Pentoxifylline
    • Drug: Vitamin E
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2012)
54
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2007)
56
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with histologically documented cancer of the breast or DCIS or head and neck referred for definitive radiation with curative intent.
  • No evidence of metastatic disease.
  • Minimum life expectancy of at least 12 months.
  • Aged greater than 20 years.
  • If female, pregnancy excluded.
  • No documented history of collagen vascular disease.

Exclusion Criteria:

  • Cognitively impaired patients
  • Prisoners
  • No histology available
  • Documented metastatic disease
  • Allergy to Trental
  • Life expectance of less than 12 months.
  • Aged less than 20 years
  • Collagen vascular disease present
  • Pregnant
  • History of liver disease
  • Use of anticoagulants
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00583700
Other Study ID Numbers  ICMJE 200211003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Iowa
Study Sponsor  ICMJE University of Iowa
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Geraldine Jacobson, MD MPH department of radiation oncology
PRS Account University of Iowa
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP