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Clinical Trials/NCT01279018
NCT01279018
Completed
Not Applicable

Persistent Pain After Breast Cancer Treatment With Docetaxel

Rigshospitalet, Denmark0 sites2,490 target enrollmentOctober 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Neoplasms
Sponsor
Rigshospitalet, Denmark
Enrollment
2490
Primary Endpoint
Docetaxel as a risk factor for development of persistent pain
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

Breast cancer treatment is for many patients followed by sequelae, such as persistent pain, sensory disturbances, lymphedema and reduced physical function. These undesired consequences of the treatment are a major clinical problem, with persistent pain affecting 25-60%, sensory disturbances 20-80%, lymphedema 2-86% and reduced physical function 13-28% of patients. Development of persistent pain after breast cancer treatment, involves a complex pathophysiology that involves pre-, intra- and postoperative factors. Several risk factors for the development of persistent pain after breast cancer treatment have been identified; young age, psychosocial factors, surgical procedure and radiation therapy. Neurotoxicity is a well know attribute of many chemotherapeutic agents, such as taxanes. The purpose of this nationwide study is to retrospectively examine a cohort of breast cancer patients treated with docetaxel, to clarify if docetaxel may influence the prevalence and intensity of persistent pain and other sequelae.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
January 2011
Last Updated
15 years ago
Study Type
Observational
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Treated for primary breast cancer in Denmark 2007-2008
  • Age between 18-80 years
  • No recurrent cancer

Exclusion Criteria

  • Previous breast surgery same side (including plastic and reconstructive surgery)
  • Bilateral breast surgery
  • Recurrent cancer or metastatic cancer

Outcomes

Primary Outcomes

Docetaxel as a risk factor for development of persistent pain

Time Frame: Between 2-3 years post surgery

Secondary Outcomes

  • Prevalence of persistent pain, sensory disturbances, lymphedema and functional limitations(Between 2-3 years post surgery)

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