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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
History of Changes
Results First Received: October 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   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
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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.
Total Total of all reporting groups

Baseline Measures
    Control Arm     Intervention: Pentoxifylline & Vitamin E     Total  
Number of Participants  
[units: participants]
 		  27     27     54  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     25     18     43  
>=65 years     2     9     11  
Age  
[units: years]
Mean ± Standard Deviation 		  54.7  ± 10.81     59.65  ± 11.74     56.81  ± 11.54  
Gender  
[units: participants]
 		     
Female     27     27     54  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     27     27     54  



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

2.  Secondary:   Tissue Compliance   [ Time Frame: 18 months post-treatment ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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.  


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
Health Authority: United States: Institutional Review Board