Pain, Postoperative Clinical Trial
Official title:
Persistent Pain After Breast Cancer Treatment With Docetaxel
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.
Status | Completed |
Enrollment | 2490 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Docetaxel as a risk factor for development of persistent pain | Between 2-3 years post surgery | No | |
Secondary | Prevalence of persistent pain, sensory disturbances, lymphedema and functional limitations | Between 2-3 years post surgery | No |
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