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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Fibrosis
Interventions: Drug: Pentoxifylline
Drug: Vitamin E

  Participant Flow

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
 27   27   54 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   25   18   43 
>=65 years   2   9   11 
[Units: Years]
Mean (Standard Deviation)
 54.7  (10.81)   59.65  (11.74)   56.81  (11.54) 
[Units: Participants]
Female   27   27   54 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
United States   27   27   54 

  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

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

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


Responsible Party: University of Iowa Identifier: NCT00583700     History of Changes
Other Study ID Numbers: 200211003
First Submitted: December 20, 2007
First Posted: December 31, 2007
Results First Submitted: October 18, 2012
Results First Posted: January 29, 2013
Last Update Posted: January 29, 2013