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

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00188669
• Other study ID #: UNH REB 02-0137-C
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: August 10, 2010
• Start date: July 2002

Study information

• Verified date: August 2010
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• pentoxifylline

• alpha-Tocopherol

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess improvement in breast pain with use of the interventional agents.
Primary	To assess improvement in patient function with the use of the interventional agents.
Secondary	To assess time to maximal improvement in pain, durability of response, quality of life changes during the study
Secondary	To qualitatively characterise presenting pain syndromes
Secondary	To examine techniques for objective assessment of breast edema and texture/fibrotic changes
Secondary	To investigate the feasibility of the use of high resolution (40MHz) ultrasound and whether changes can be measured