Persistent Pain After Breast Cancer Treatment With Docetaxel
This study has been completed.
First Posted: January 19, 2011
Last Update Posted: January 19, 2011
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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.
|Breast Neoplasms Pain, Postoperative Neuralgia Lymphedema|
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Persistent Pain After Breast Cancer Treatment With Docetaxel|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Rigshospitalet, Denmark:
Primary Outcome Measures:
- Docetaxel as a risk factor for development of persistent pain [ Time Frame: Between 2-3 years post surgery ]
Secondary Outcome Measures:
- Prevalence of persistent pain, sensory disturbances, lymphedema and functional limitations [ Time Frame: Between 2-3 years post surgery ]
|Study Start Date:||October 2010|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Patients treated with docetaxel
Patients treated according to the DBCG 07 protocol, that have received docetaxel as part of the adjuvant treatment.
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