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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.
 
ClinicalTrials.gov Identifier: NCT00583700
Recruitment Status : Completed
First Posted : December 31, 2007
Results First Posted : January 29, 2013
Last Update Posted : January 29, 2013
Sponsor:
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
Enrollment 54
Recruitment Details 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  
Arm/Group Title Control Arm Intervention: Pentoxifylline & Vitamin E
Hide Arm/Group Description Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.

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.

Period Title: Overall Study
Started 27 27
Completed 24 23
Not Completed 3 4
Arm/Group Title Control Arm Intervention: Pentoxifylline & Vitamin E Total
Hide Arm/Group Description Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.

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 of all reporting groups
Overall Number of Baseline Participants 27 27 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
  92.6%
18
  66.7%
43
  79.6%
>=65 years
2
   7.4%
9
  33.3%
11
  20.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 27 participants 54 participants
54.7  (10.81) 59.65  (11.74) 56.81  (11.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 participants
Female
27
 100.0%
27
 100.0%
54
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 27 participants 54 participants
27 27 54
1.Primary Outcome
Title Subjective, Objective, Management, and Analytic (SOMA) Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the study were evaluated for SOMA scores. Numbers varied by study participants compliance with follow-up appointments.
Arm/Group Title Control Arm Intervention: Pentoxifylline & Vitamin E
Hide Arm/Group Description:
Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.

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.

Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.59  (1.53) 1.0  (1.19)
2.Secondary Outcome
Title Tissue Compliance
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Control Arm Intervention: Pentoxifylline & Vitamin E
Hide Arm/Group Description:
Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.

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.

Overall Number of Participants Analyzed 24 23
Mean (Standard Deviation)
Unit of Measure: milimeters (mm)
2.10  (2.16) 0.88  (1.96)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Arm Intervention: Pentoxifylline & Vitamin E
Hide Arm/Group Description Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.

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.

All-Cause Mortality
Control Arm Intervention: Pentoxifylline & Vitamin E
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Control Arm Intervention: Pentoxifylline & Vitamin E
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/27 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control Arm Intervention: Pentoxifylline & Vitamin E
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/27 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Geraldine Jacobson, MD, MBA, MPH, FACR
Organization: West Virginia University
Phone: (304) 293-7227
EMail: GMJACOBSON@hsc.wvu.edu
Layout table for additonal information
Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT00583700    
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