Status:
TERMINATED
The Use of Pentoxifylline and Vitamin E in the Treatment of Chronic Breast Pain
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Princess Margaret Hospital, Canada
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
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 ch...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00188669
Start Date
July 1 2002
Last Update
August 11 2010
Active Locations (1)
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1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9