Persistent Pain After Breast Cancer Treatment With Docetaxel

NCT ID: NCT01279018

Last Updated: 2011-01-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2490 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-01-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients treated with docetaxel

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

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Rigshospitalet, Section for Surgical Pathophysiology

Other Identifiers

H-1-2010-028

Identifier Type: -

Identifier Source: org_study_id