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

This study is currently recruiting participants.

Verified by University Health Network, Toronto, September 2005

Sponsors and Collaborators:	University Health Network, Toronto Princess Margaret Hospital, Canada
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00188552

Purpose

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.

Condition	Intervention	Phase
Wounds and Injuries	Drug: pentoxifylline Drug: α-Tocopherol	Phase II

MedlinePlus related topics: Injuries Wounds

Drug Information available for: Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Pentoxifylline Pentoxyl

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of the Use of Pentoxifylline and Vitamin E in the Treatment of Late Radiation Related Injuries

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

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

Secondary Outcome 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.)

Estimated Enrollment:	50
Study Start Date:	July 2002

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188552

Contacts

Contact: Wilfred Levin, MD

416-946-2127

wilfred.levin@rmp.uhn.on.ca

Locations

Canada, Ontario
Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Wilfred Levin, MD 416-946-2127 wilfred.levin@rmp.uhn.on.ca

Sponsors and Collaborators

University Health Network, Toronto

Princess Margaret Hospital, Canada

Investigators

Principal Investigator:

Wilfred Levin, MD

Princess Margaret Hospital, Canada

More Information

Study ID Numbers:	UHN REB 01-0244-C
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00188552
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Tocopherols
Tocopherol acetate
Vitamin E
Wounds and Injuries

Disorders of Environmental Origin
Pentoxifylline
Alpha-Tocopherol

Additional relevant MeSH terms:

Radiation-Protective Agents
Vasodilator Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents

Protective Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Vitamins
Therapeutic Uses
Free Radical Scavengers
Platelet Aggregation Inhibitors
Micronutrients

ClinicalTrials.gov processed this record on January 16, 2009