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

NCT00188669 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2010-08-11

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms

Interventions

DRUG

pentoxifylline

DRUG

alpha-Tocopherol

Sponsors & Collaborators

  • Princess Margaret Hospital, Canada

    collaborator OTHER
  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Wilfred Levin, MD · Princess Margaret Hospital, Canada

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00188669 on ClinicalTrials.gov