Official Title: “A Phase II Study of the Use of Pentoxifylline and Vitamin E in the Treatment of Late Radiation Related Injuries”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: pentoxifylline
• Drug: α-Tocopherol

Primary Measures

• To examine the effect of the combination of Pentoxifylline (Trental™) and α-Tocopherol (Vitamin E) on symptomatic radiation induced fibrosis.

Secondary Measures

• To examine the effect of the combination of Pentoxifylline (Trental™) and α-Tocopherol (Vitamin E) on quality of life in patients with radiation induced fibrosis
• To examine the effect of the combination of Pentoxifylline (Trental™) and α-Tocopherol (Vitamin E) on other patient outcomes, including:
• ECOG Performance status
• To identify factors which modify patients’ response to protocol therapy (e.g. radiotherapy treatment factors, prior surgeries, chemotherapy, patient characteristics, etc.)

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Health Network, Toronto

Overall Clinical Trial Officials and Contacts

Wilfred Levin, MD Principal Investigator Princess Margaret Hospital, Canada  

Overall Contact: Wilfred Levin, MD 416-946-2127 wilfred.levin@rmp.uhn.on.ca

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00188552

Study ID Number: UHN REB 01-0244-C

ClinicalTrials.gov Identifier: NCT00188552

Health Authority: Canada: Health Canada