We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trental & Vitamin E for Radiation-Induced Fibrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00583700
First Posted: December 31, 2007
Last Update Posted: January 29, 2013
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.
Information provided by (Responsible Party):
University of Iowa
Results First Submitted: October 18, 2012  
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
  Hide Participant Flow

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
  Hide 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.
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.

Total Total of all reporting groups

Baseline Measures
   Control Arm   Intervention: Pentoxifylline & Vitamin E   Total 
Overall Participants Analyzed 
[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
  Hide All Outcome Measures

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

Measure Type Primary
Measure Title Subjective, Objective, Management, and Analytic (SOMA) Score
Measure Description 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.
Time Frame 18 month post-treatment  

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.
All participants enrolled in the study were evaluated for SOMA scores. Numbers varied by study participants compliance with follow-up appointments.

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.


Measured Values
   Control Arm   Intervention: Pentoxifylline & Vitamin E 
Participants Analyzed 
[Units: Participants]
 27   25 
Subjective, Objective, Management, and Analytic (SOMA) Score 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.59  (1.53)   1.0  (1.19) 

No statistical analysis provided for Subjective, Objective, Management, and Analytic (SOMA) Score



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

Measure Type Secondary
Measure Title Tissue Compliance
Measure Description

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.

Time Frame 18 months post-treatment  

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.
All study participants enrolled were to be measured at 18 months post-radiotherapy. The number of participants analyzed varied by the number compliant with study schedule.

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.


Measured Values
   Control Arm   Intervention: Pentoxifylline & Vitamin E 
Participants Analyzed 
[Units: Participants]
 24   23 
Tissue Compliance 
[Units: Milimeters (mm)]
Mean (Standard Deviation)
 2.10  (2.16)   0.88  (1.96) 

No statistical analysis provided for Tissue Compliance




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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
e-mail: GMJACOBSON@hsc.wvu.edu


Publications:

Responsible Party: University of Iowa
ClinicalTrials.gov 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



To Top