Persistent Pain After Breast Cancer Treatment With Docetaxel

Completed

• Conditions: Pain, Postoperative; Breast Neoplasms; Neuralgia; Lymphedema

• Registration Number: NCT01279018
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-06
• Study Start: 2010-10
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-18
• Last Update Submitted: 2011-01-18
• Study First Posted: 2011-01-19
• Last Update Posted: 2011-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2490

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Docetaxel as a risk factor for development of persistent pain	Between 2-3 years post surgery

Secondary Outcome Measures

Name	Time	Method
Prevalence of persistent pain, sensory disturbances, lymphedema and functional limitations	Between 2-3 years post surgery