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TerminatedNCT00188669Updated Aug 11, 2010

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

A Phase 2 interventional study of pentoxifylline and alpha-Tocopherol in Breast Neoplasms, sponsored by University Health Network, Toronto. Terminated at 1 site in Canada. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-08-11.

Sponsored by University Health Network, Toronto · Phase 2, Interventional, and Treatment

Why this study was terminated
date: August 2006. No annual renewal
Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Neoplasms
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 48 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (estimated)

Interventions

  • Drugpentoxifylline
  • Drugalpha-Tocopherol
06

What researchers measure

Primary outcomes

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

  2. To assess improvement in patient function with the use of the interventional agents.

Secondary outcomes

  1. To assess time to maximal improvement in pain, durability of response, quality of life changes during the study

  2. To qualitatively characterise presenting pain syndromes

  3. To examine techniques for objective assessment of breast edema and texture/fibrotic changes

  4. To investigate the feasibility of the use of high resolution (40MHz) ultrasound and whether changes can be measured

07

Study locations

1 site
  • Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00188669
Lead sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
First posted
Sep 16, 2005
Start date
Jul 2002
Last update
Aug 11, 2010

Study contacts

Wilfred Levin, MD
principal investigator · Princess Margaret Hospital, Canada
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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