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

University Health Network, Toronto

Status and phase

Terminated

Phase 2

Conditions

Breast Neoplasms

Treatments

Drug: alpha-Tocopherol

Drug: pentoxifylline

Study type

Interventional

Funder types

Other

Identifiers

NCT00188669

UNH REB 02-0137-C

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No 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