A Phase II Study of the Use of Pentoxifylline and a-Tocopherol in the Treatment of Chronic Breast Pain Associated With Breast Radiotherapy
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