Phase 2
N=54
Trental & Vitamin E for Radiation-Induced Fibrosis
Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00583700 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Subjective, Objective, Management, and Analytic (SOMA) Score — 1.59; 1.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pentoxifylline (Drug); Vitamin E (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- University of Iowa
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective, Objective, Management, and Analytic (SOMA) Score |
1.59; 1.0 | — |
| SECONDARY Tissue Compliance |
2.10; 0.88 | — |
Summary
This study seeks to determine if a combination of Trental and Vitamin E prevents the development of radiation fibrosis in women treated with radiation for the definitive management of their breast cancer.
Eligibility Criteria
Inclusion Criteria
- Patients with histologically documented cancer of the breast or DCIS or head and neck referred for definitive radiation with curative intent.
- No evidence of metastatic disease.
- Minimum life expectancy of at least 12 months.
- Aged greater than 20 years.
- If female, pregnancy excluded.
- No documented history of collagen vascular disease.
Exclusion Criteria
- Cognitively impaired patients
- Prisoners
- No histology available
- Documented metastatic disease
- Allergy to Trental
- Life expectance of less than 12 months.
- Aged less than 20 years
- Collagen vascular disease present
- Pregnant
- History of liver disease
- Use of anticoagulants
Data sourced from ClinicalTrials.gov (NCT00583700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.