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

January 14, 2011
January 18, 2011
October 2010
January 2011   (final data collection date for primary outcome measure)
Docetaxel as a risk factor for development of persistent pain [ Time Frame: Between 2-3 years post surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01279018 on ClinicalTrials.gov Archive Site
Prevalence of persistent pain, sensory disturbances, lymphedema and functional limitations [ Time Frame: Between 2-3 years post surgery ] [ Designated as safety issue: No ]
Same as current
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Persistent Pain After Breast Cancer Treatment With Docetaxel
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.

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Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

Patients treated for breast cancer in Denmark 2007 and 2008

  • Breast Neoplasms
  • Pain, Postoperative
  • Neuralgia
  • Lymphedema
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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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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2490
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 80 Years
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Contact information is only displayed when the study is recruiting subjects
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NCT01279018
H-1-2010-028
No
Kenneth Geving Andersen, MD, Rigshospitalet, Section for Surgical Pathophysiology
Rigshospitalet, Denmark
Not Provided
Not Provided
Rigshospitalet, Denmark
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP