Status:
TERMINATED
The Use of Pentoxifylline and Vitamin E in the Treatment of Late Radiation Related Injuries
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Princess Margaret Hospital, Canada
Conditions:
Wounds and Injuries
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Patients with radiation induced injuries experience significant pain and negative effects on quality of life. Currently, no standard therapy for these patients exists, with some patients treated sympt...
Eligibility Criteria
Inclusion
- Clinically documented symptomatic radiation induced injury (e.g. fibrosis, necrosis, ulceration)
- Prior treatment with radiation therapy to the affected area - completed at least 3 months prior to study entry
- Pain in irradiated volume after 3 months (not attributable to acute inflammation)
- ECOG performance status must be 0, 1 or 2
- Life expectancy is greater than 6 months
- Age 18 to 75 years; informed consent
Exclusion
- Patient is still responding to other therapies for soft tissue injury
- Active malignant disease
- Any medical illness or condition judged likely by the local investigator to preclude safe administration of protocol treatment, including but not limited to, acute myocardial infarction, severe coronary artery disease, active internal bleeding or a history of hemorrhagic diathesis, peptic ulcer, impaired kidney or liver function
- Pregnant or lactating women
- No contraindication to treatment with pentoxifylline. (i.e. previously exhibited intolerance to pentoxifylline or other xanthines such as caffeine, theophylline or theobromine, recent cerebral and/or retinal hemorrhage)
- Concurrent treatment with warfarin or other anticoagulant, or with erythromycin
- Concurrent treatment with other experimental agents or other treatment for fibrosis
- Patients treated with radiotherapy for breast cancer 3 months to 3 years prior to study entry
- Blood pressure \< 90/60 mm Hg or orthostatic hypotension
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00188552
Start Date
July 1 2002
Last Update
August 13 2010
Active Locations (1)
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1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9