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


Phase 2
18 Years
75 Years
Not Enrolling
Female
Breast Neoplasms

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Trial Information

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess improvement in breast pain with use of the interventional agents.

Principal Investigator

Wilfred Levin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

Canada: Health Canada

Study ID:

UNH REB 02-0137-C

NCT ID:

NCT00188669

Start Date:

July 2002

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms

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