Clinical trial · Interventional
Trental & Vitamin E for Radiation-Induced Fibrosis
Development of Radiation Fibrosis in Patients Treated With Pentoxyphylline and Vitamin E: a Prospective Randomized Study
NCT00583700CI-TRIAL-00009186completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibrosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pentoxifylline | Drug | — | UNRESOLVED |
| Vitamin E | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- 1
- description
- Control for study - watchful waiting.
- type
- EXPERIMENTAL
- label
- 2
- description
- Combined treatment with Pentoxifylline and Vitamin E.
- interventionNames
- Drug: Pentoxifylline
- Drug: Vitamin E
Primary outcomes (1)
- measure
- Subjective, Objective, Management, and Analytic (SOMA) Score
- timeFrame
- 18 month post-treatment
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDDion MW, Hussey DH, Doornbos JF, Vigliotti AP, Wen BC, Anderson B. Preliminary results of a pilot study of pentoxifylline in the treatment of late radiation soft tissue necrosis. Int J Radiat Oncol Biol Phys. 1990 Aug;19(2):401-7. doi: 10.1016/0360-3016(90)90549-y. PMID 2394619
- BACKGROUNDDelanian S, Balla-Mekias S, Lefaix JL. Striking regression of chronic radiotherapy damage in a clinical trial of combined pentoxifylline and tocopherol. J Clin Oncol. 1999 Oct;17(10):3283-90. doi: 10.1200/JCO.1999.17.10.3283. PMID 10506631
- BACKGROUNDDelanian S, Porcher R, Balla-Mekias S, Lefaix JL. Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis. J Clin Oncol. 2003 Jul 1;21(13):2545-50. doi: 10.1200/JCO.2003.06.064. PMID 12829674
- BACKGROUNDGothard L, Cornes P, Earl J, Hall E, MacLaren J, Mortimer P, Peacock J, Peckitt C, Woods M, Yarnold J. Double-blind placebo-controlled randomised trial of vitamin E and pentoxifylline in patients with chronic arm lymphoedema and fibrosis after surgery and radiotherapy for breast cancer. Radiother Oncol. 2004 Nov;73(2):133-9. doi: 10.1016/j.radonc.2004.09.013. PMID 15542159
- BACKGROUNDDelanian S, Porcher R, Rudant J, Lefaix JL. Kinetics of response to long-term treatment combining pentoxifylline and tocopherol in patients with superficial radiation-induced fibrosis. J Clin Oncol. 2005 Dec 1;23(34):8570-9. doi: 10.1200/JCO.2005.02.4729. Epub 2005 Oct 31. PMID 16260695