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

Wounds and Injuries Clinical Trial

Official title:

A Phase II Study of the Use of Pentoxifylline and Vitamin E in the Treatment of Late Radiation Related Injuries

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00188552
• Other study ID #: UHN REB 01-0244-C
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: August 12, 2010
• Start date: July 2002

Study information

• Verified date: August 2010
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wounds and Injuries

Intervention

Drug:
• pentoxifylline

• a-Tocopherol

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine the effect of the combination of Pentoxifylline (Trental™) and a-Tocopherol (Vitamin E) on symptomatic radiation induced fibrosis.
Secondary	To examine the effect of the combination of Pentoxifylline (Trental™) and a-Tocopherol (Vitamin E) on quality of life in patients with radiation induced fibrosis
Secondary	To examine the effect of the combination of Pentoxifylline (Trental™) and a-Tocopherol (Vitamin E) on other patient outcomes, including:
Secondary	ECOG Performance status
Secondary	To identify factors which modify patients' response to protocol therapy (e.g. radiotherapy treatment factors, prior surgeries, chemotherapy, patient characteristics, etc.)