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
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

Patients treated for breast cancer in Denmark 2007 and 2008

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  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 July 23, 2014