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

NCT ID: NCT00188552

Last Updated: 2010-08-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31

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 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.

Conditions

Wounds and Injuries

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

pentoxifylline

Intervention Type: DRUG

α-Tocopherol

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Principal Investigators

Wilfred Levin, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN REB 01-0244-C

Identifier Type: -

Identifier Source: org_study_id