Trial Outcomes & Findings for Trental & Vitamin E for Radiation-Induced Fibrosis (NCT NCT00583700)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

18 month post-treatment

Results posted on

2013-01-29

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	27	27
Overall Study COMPLETED	24	23
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trental & Vitamin E for Radiation-Induced Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Arm n=27 Participants Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.	Intervention: Pentoxifylline & Vitamin E n=27 Participants 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 n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	18 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Age Continuous	54.7 years STANDARD_DEVIATION 10.81 • n=5 Participants	59.65 years STANDARD_DEVIATION 11.74 • n=7 Participants	56.81 years STANDARD_DEVIATION 11.54 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	27 participants n=7 Participants	54 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 month post-treatment

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

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.

Outcome measures

Outcome measures
Measure	Control Arm n=27 Participants Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.	Intervention: Pentoxifylline & Vitamin E n=25 Participants 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.
Subjective, Objective, Management, and Analytic (SOMA) Score	1.59 units on a scale Standard Deviation 1.53	1.0 units on a scale Standard Deviation 1.19

SECONDARY outcome

Timeframe: 18 months post-treatment

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Control Arm n=24 Participants Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.	Intervention: Pentoxifylline & Vitamin E n=23 Participants 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.
Tissue Compliance	2.10 milimeters (mm) Standard Deviation 2.16	0.88 milimeters (mm) Standard Deviation 1.96

Adverse Events

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention: Pentoxifylline & Vitamin E

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Geraldine Jacobson, MD, MBA, MPH, FACR

West Virginia University

Phone: (304) 293-7227

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place