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The Use of Pentoxifylline and Vitamin E in the Treatment of Chronic Breast Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00188669
Recruitment Status : Terminated (date: August 2006. No annual renewal)
First Posted : September 16, 2005
Last Update Posted : August 11, 2010
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto

Brief Summary:
An estimated 20 - 45 % of women treated with breast conserving treatment experience chronic pain in the treated breast. The aetiology of this is poorly understood. Some of these women have signs of chronic radiation mastitis. There is no accepted treatment for this condition. The combination of pentoxifylline and vitamin E has been shown to be effective in reversing radiation fibrosis in this region. Many of these patients have had a benefit in pain response in a time period of a few benefits. This study is a phase II study of these drugs for a 6 month trial period to assess the effect on chronic breast pain in breast cancer patients who are 3 months to 3 years post radiation treatment.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: pentoxifylline Drug: alpha-Tocopherol Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of the Use of Pentoxifylline and a-Tocopherol in the Treatment of Chronic Breast Pain Associated With Breast Radiotherapy
Study Start Date : July 2002

Primary Outcome Measures :
  1. To assess improvement in breast pain with use of the interventional agents.
  2. To assess improvement in patient function with the use of the interventional agents.

Secondary Outcome Measures :
  1. To assess time to maximal improvement in pain, durability of response, quality of life changes during the study
  2. To qualitatively characterise presenting pain syndromes
  3. To examine techniques for objective assessment of breast edema and texture/fibrotic changes
  4. To investigate the feasibility of the use of high resolution (40MHz) ultrasound and whether changes can be measured

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • UICC TNM stage 0 (i.e. in situ disease), 1 or 2 breast cancer patients treated with conservative surgery and adjuvant radiotherapy with chronic breast pain or tenderness, with or without fibrosis, within 3 months to 3 years following completion of radiotherapy
  • Age 18 to 75 years of age
  • Chronic symptoms localised to the breast treated with radiation, i.e. any one or more of the following- pain (not attributable to infection) or tenderness with or without associated oedema, fibrosis, necrosis or ulceration.
  • Breast pain (maximum in the previous 24 hours) measurable on a Linear Analogue Scale with a length of 3cm or greater
  • Prior treatment with radiation to the affected area i.e. in tangential breast fields or boost area
  • Radiation completed at least 3 months and no longer than 3 years prior to study entry
  • Informed consent

Exclusion Criteria:

  • Active cellulitis in the breast
  • Active malignant disease
  • Any medical illness or condition judged likely by the local investigator to preclude safe administration of protocol treatment
  • 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 haemorrhage; ischaemic heart disease; hypotension
  • Pregnant or lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00188669

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Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
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Principal Investigator: Wilfred Levin, MD Princess Margaret Hospital, Canada
Layout table for additonal information Identifier: NCT00188669    
Other Study ID Numbers: UNH REB 02-0137-C
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 11, 2010
Last Verified: August 2010
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neurologic Manifestations
Vitamin E
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Growth Substances