Persistent Pain After Breast Cancer Treatment With Docetaxel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01279018
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : January 19, 2011
Information provided by:
Rigshospitalet, Denmark

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.

Condition or disease
Breast Neoplasms Pain, Postoperative Neuralgia Lymphedema

Study Type : Observational
Actual Enrollment : 2490 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Persistent Pain After Breast Cancer Treatment With Docetaxel
Study Start Date : October 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel
U.S. FDA Resources

Patients treated with docetaxel
Patients treated according to the DBCG 07 protocol, that have received docetaxel as part of the adjuvant treatment.

Primary Outcome Measures :
  1. Docetaxel as a risk factor for development of persistent pain [ Time Frame: Between 2-3 years post surgery ]

Secondary Outcome Measures :
  1. Prevalence of persistent pain, sensory disturbances, lymphedema and functional limitations [ Time Frame: Between 2-3 years post surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
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

Responsible Party: Kenneth Geving Andersen, MD, Rigshospitalet, Section for Surgical Pathophysiology Identifier: NCT01279018     History of Changes
Other Study ID Numbers: H-1-2010-028
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: June 2010

Keywords provided by Rigshospitalet, Denmark:
Persistent postsurgical pain
breast cancer
postmastectomy pain syndrome
neuropathic pain

Additional relevant MeSH terms:
Breast Neoplasms
Pain, Postoperative
Neoplasms by Site
Breast Diseases
Skin Diseases
Lymphatic Diseases
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action