The Use of Pentoxifylline and Vitamin E in the Treatment of Late Radiation Related Injuries

University Health Network, Toronto

Status and phase

Terminated

Phase 2

Conditions

Wounds and Injuries

Treatments

Drug: pentoxifylline

Drug: α-Tocopherol

Study type

Interventional

Funder types

Other

Identifiers

NCT00188552

UHN REB 01-0244-C

Details and patient eligibility

About

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 symptomatically, and others treated with hyperbaric oxygen or pentoxifylline/Vitamin E. This study will examine prospectively the safety and efficacy of using a regimen of pentoxifylline and vitamin E in patients with late radiation induced injuries.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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