Persistent Pain After Breast Cancer Treatment With Docetaxel

This study has been completed.

Sponsor:

Information provided by:

Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT01279018

First received: January 14, 2011

Last updated: January 18, 2011

Last verified: June 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	January 14, 2011
Last Updated Date	January 18, 2011
Start Date ^ICMJE	October 2010
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 18, 2011)	Docetaxel as a risk factor for development of persistent pain [ Time Frame: Between 2-3 years post surgery ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01279018 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 18, 2011)	Prevalence of persistent pain, sensory disturbances, lymphedema and functional limitations [ Time Frame: Between 2-3 years post surgery ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Persistent Pain After Breast Cancer Treatment With Docetaxel
Official Title ^ICMJE	Persistent Pain After Breast Cancer Treatment With Docetaxel
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 Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients treated for breast cancer in Denmark 2007 and 2008
Condition ^ICMJE	Breast Neoplasms Pain, Postoperative Neuralgia Lymphedema
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Patients treated with docetaxel Patients treated according to the DBCG 07 protocol, that have received docetaxel as part of the adjuvant treatment.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	2490
Completion Date	January 2011
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01279018
Other Study ID Numbers ^ICMJE	H-1-2010-028
Has Data Monitoring Committee	No
Responsible Party	Kenneth Geving Andersen, MD, Rigshospitalet, Section for Surgical Pathophysiology
Study Sponsor ^ICMJE	Rigshospitalet, Denmark
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Rigshospitalet, Denmark
Verification Date	June 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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