ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Trental & Vitamin E for Radiation-Induced Fibrosis

This study is currently recruiting participants.
Verified by University of Iowa, June 2008

Sponsored by: University of Iowa
Information provided by: University of Iowa
ClinicalTrials.gov Identifier: NCT00583700
  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
Other: control
Phase II

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

Drug Information available for:   Vitamin E    alpha-Tocopherol    alpha-Tocopheryl acetate    Tocopherols    Pentoxifylline    Pentoxyl   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:   Development of Radiation Fibrosis in Patients Treated With Pentoxyphylline and Vitamin E: a Prospective Randomized Study

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • The primary outcome of interest is composite SOMA score at 18-month follow-up visit [ Time Frame: 18 month post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tissue compliance of the treated breast compared to the non-treated breast [ Time Frame: 12 and 18 months post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:   56
Study Start Date:   February 2003
Estimated Study Completion Date:   December 2009
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: No Intervention
Control for study - watchful waiting.
Other: control
No Pentoxifylline, no Vitamin E. Observation for 7 months, only.
2: Experimental
Combined treatment with Pentoxifylline and Vitamin E.
Drug: Pentoxifylline
Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy.
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583700

Contacts
Contact: Kellie Bodeker, B.Sc., CCRC     (319) 384-9425     kellie-bodeker@uiowa.edu    
Contact: Jane Hershberger, R.N.     (319) 353-8973     jane-hershberger@uiowa.edu    

Locations
United States, Iowa
The University of Iowa Hospitals & Clinics     Recruiting
      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


Publications:

Responsible Party:   Department of radiation Oncology ( Geraldine Jacobson, MD, MPH )
Study ID Numbers:   200211003
First Received:   December 20, 2007
Last Updated:   June 9, 2008
ClinicalTrials.gov Identifier:   NCT00583700
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Iowa:
Breast Neoplasms  
Radiotherapy  

Study placed in the following topic categories:
Tocopherols
Tocopherol acetate
Vitamin E
Fibrosis
Breast Neoplasms
Radiation Pneumonitis
Pentoxifylline
Alpha-Tocopherol

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

ClinicalTrials.gov processed this record on October 31, 2008




Links to all studies - primarily for crawlers