Trental & Vitamin E for Radiation-Induced Fibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT00583700
First received: December 20, 2007
Last updated: December 18, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Fibrosis
Drug: Pentoxifylline
Drug: Vitamin E
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Development of Radiation Fibrosis in Patients Treated With Pentoxyphylline and Vitamin E: a Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Subjective, Objective, Management, and Analytic (SOMA) Score [ Time Frame: 18 month post-treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Tissue Compliance [ Time Frame: 18 months post-treatment ] [ Designated as safety issue: No ]

    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.



Enrollment: 54
Study Start Date: February 2003
Study Completion Date: June 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Control for study - watchful waiting.
Experimental: 2
Combined treatment with Pentoxifylline and Vitamin E.
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00583700

Locations
United States, Iowa
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Geraldine Jacobson, MD MPH department of radiation oncology
  More Information

Additional Information:
Publications:
Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT00583700     History of Changes
Other Study ID Numbers: 200211003
Study First Received: December 20, 2007
Results First Received: October 18, 2012
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Breast Neoplasms
Radiotherapy

Additional relevant MeSH terms:
Fibrosis
Pathologic Processes
Vitamins
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Pentoxifylline
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Radiation-Protective Agents
Vasodilator Agents
Cardiovascular Agents
Free Radical Scavengers

ClinicalTrials.gov processed this record on September 18, 2014