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

This study has been terminated.
(May 2007: No annual renewal)
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188552
First received: September 12, 2005
Last updated: August 12, 2010
Last verified: August 2010
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of the Use of Pentoxifylline and Vitamin E in the Treatment of Late Radiation Related Injuries

Resource links provided by NLM:

U.S. FDA Resources

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

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Wilfred Levin, MD Princess Margaret Hospital, Canada
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00188552     History of Changes
Other Study ID Numbers: UHN REB 01-0244-C
Study First Received: September 12, 2005
Last Updated: August 12, 2010
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Wounds and Injuries
Pentoxifylline
Vitamin E
Tocopherols
Tocotrienols
Vitamins
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Platelet Aggregation Inhibitors
 Hematologic Agents
Therapeutic Uses
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Cardiovascular Agents
Free Radical Scavengers
Antioxidants
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013