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

Primary Purpose

Breast Neoplasms

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
pentoxifylline
alpha-Tocopherol
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Princess Margaret Hospital

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
August 10, 2010
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00188669
Brief Title
The Use of Pentoxifylline and Vitamin E in the Treatment of Chronic Breast Pain
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 Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Terminated
Why Stopped
date: August 2006. No annual renewal
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pentoxifylline
Intervention Type
Drug
Intervention Name(s)
alpha-Tocopherol
Primary Outcome Measure Information:
Title
To assess improvement in breast pain with use of the interventional agents.
Title
To assess improvement in patient function with the use of the interventional agents.
Secondary Outcome Measure Information:
Title
To assess time to maximal improvement in pain, durability of response, quality of life changes during the study
Title
To qualitatively characterise presenting pain syndromes
Title
To examine techniques for objective assessment of breast edema and texture/fibrotic changes
Title
To investigate the feasibility of the use of high resolution (40MHz) ultrasound and whether changes can be measured

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfred Levin, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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