Persistent Pain After Breast Cancer Treatment With Docetaxel

Pain, Postoperative Clinical Trial

Official title:

Persistent Pain After Breast Cancer Treatment With Docetaxel

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279018
• Other study ID #: H-1-2010-028
• Status: Completed
• Phase: N/A
• First received: January 14, 2011
• Last updated: January 18, 2011
• Start date: October 2010
• Est. completion date: January 2011

Study information

• Verified date: June 2010
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2490
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Neoplasms
• Lymphedema
• Neuralgia
• Pain, Postoperative

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Docetaxel as a risk factor for development of persistent pain		Between 2-3 years post surgery	No
Secondary	Prevalence of persistent pain, sensory disturbances, lymphedema and functional limitations		Between 2-3 years post surgery	No