Persistent Pain After Breast Cancer Treatment With Docetaxel

NCT01279018 | Completed

• 1 other identifier: H-1-2010-028
• Study Type: observational
• Target: 2,490
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Neoplasms; Pain, Postoperative; Neuralgia; Lymphedema

Keywords

Persistent postsurgical pain; breast cancer; postmastectomy pain syndrome; neuropathic pain

Outcome Measures

Primary Outcomes (1)

• Docetaxel as a risk factor for development of persistent pain

  Between 2-3 years post surgery

Secondary Outcomes (1)

• Prevalence of persistent pain, sensory disturbances, lymphedema and functional limitations

  Between 2-3 years post surgery

Study Arms (1)

Patients treated with docetaxel

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated for breast cancer in Denmark 2007 and 2008

You may qualify if:

• Treated for primary breast cancer in Denmark 2007-2008
• Age between 18-80 years
• No recurrent cancer
• Female

You may not qualify if:

• Previous breast surgery same side (including plastic and reconstructive surgery)
• Bilateral breast surgery
• Recurrent cancer or metastatic cancer

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative; Neuralgia; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 19, 2011
• Study Start: October 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 19, 2011

Record last verified: 2010-06