Persistent Pain After Breast Cancer Treatment With Docetaxel
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Purpose
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.
| Condition |
|---|
|
Breast Neoplasms Pain, Postoperative Neuralgia Lymphedema |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Persistent Pain After Breast Cancer Treatment With Docetaxel |
- Docetaxel as a risk factor for development of persistent pain [ Time Frame: Between 2-3 years post surgery ] [ Designated as safety issue: No ]
- Prevalence of persistent pain, sensory disturbances, lymphedema and functional limitations [ Time Frame: Between 2-3 years post surgery ] [ Designated as safety issue: No ]
| Enrollment: | 2490 |
| Study Start Date: | October 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Patients treated with docetaxel
Patients treated according to the DBCG 07 protocol, that have received docetaxel as part of the adjuvant treatment.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Sampling Method: | Non-Probability Sample |
Patients treated for breast cancer in Denmark 2007 and 2008
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Kenneth Geving Andersen, MD, Rigshospitalet, Section for Surgical Pathophysiology |
| ClinicalTrials.gov Identifier: | NCT01279018 History of Changes |
| Other Study ID Numbers: | H-1-2010-028 |
| Study First Received: | January 14, 2011 |
| Last Updated: | January 18, 2011 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency |
Keywords provided by Rigshospitalet, Denmark:
|
Persistent postsurgical pain breast cancer postmastectomy pain syndrome neuropathic pain |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Lymphedema Neuralgia Pain, Postoperative Neoplasms by Site Breast Diseases Skin Diseases Lymphatic Diseases Pain Neurologic Manifestations |
Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Postoperative Complications Pathologic Processes Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013