Text Size

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

This study has been terminated.
(date: August 2006. No annual renewal)
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188669
First received: September 12, 2005
Last updated: August 10, 2010
Last verified: August 2010
History of Changes
  Purpose

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 Intervention Phase
Breast Neoplasms
 Drug: pentoxifylline
Drug: alpha-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 a-Tocopherol in the Treatment of Chronic Breast Pain Associated With Breast Radiotherapy

Resource links provided by NLM:

U.S. FDA Resources

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

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

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

Estimated Enrollment: 48
Study Start Date: July 2002
  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00188669

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: NCT00188669     History of Changes
Other Study ID Numbers: UNH REB 02-0137-C
Study First Received: September 12, 2005
Last Updated: August 10, 2010
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Pentoxifylline
Alpha-Tocopherol
Vitamin E
Tocopherols
Tocotrienols
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
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 22, 2013