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

NCT00188552 | Terminated Phase 2

• 1 other identifier: UHN REB 01-0244-C
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• 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.)

Interventions

pentoxifylline DRUG

α-Tocopherol DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Pentoxifylline; alpha-Tocopherol

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tocopherols; Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring

Study Officials

• Wilfred Levin, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: July 1, 2002
• Last Updated: August 13, 2010

Record last verified: 2010-08

Locations

CA (1)