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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
Results First Received: October 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Fibrosis
Interventions: Drug: Pentoxifylline
Drug: Vitamin E

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between April 2003 and July 2009, 53 breast cancer patients were recruited from the University of Iowa Radiation Oncology clinic and randomized to one of two arms.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control Arm Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
Intervention: Pentoxifylline & Vitamin E

Combined treatment with Pentoxifylline and Vitamin E.

Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily

Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy.


Participant Flow:   Overall Study
    Control Arm   Intervention: Pentoxifylline & Vitamin E
STARTED   27   27 
COMPLETED   24   23 
NOT COMPLETED   3   4 



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Subjective, Objective, Management, and Analytic (SOMA) Score   [ Time Frame: 18 month post-treatment ]

2.  Secondary:   Tissue Compliance   [ Time Frame: 18 months post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small, single-institutional study. Smaller clinical trials are prone to imbalances in patient characteristics across treatment arms. t tests applied to small studies can be unduly influenced by data that contain outliers or are skewed.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Geraldine Jacobson, MD, MBA, MPH, FACR
Organization: West Virginia University
phone: (304) 293-7227
e-mail: GMJACOBSON@hsc.wvu.edu


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