Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms

Completed

• Conditions: Lymphedema; Neuropathic Pain; Persistent Pain; Breast Cancer; Neuropathy

• Registration Number: NCT01523132
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

The study is a prospective cohort study following breast cancer patients from before surgery to one year after. The aims of the study are to determine risk factors that predispose to the development of persistent pain.

Detailed Description

The aim of the study is 1) to determine pre-, intra and post surgical risk factors for persistent pain after breast cancer treatment 2) to examine the prevalence of persistent pain 6 and 12 months after surgery 3) provide a quantitative sensory testing (QST) profile of the patient population, measured pre surgery, 1 week and 12 months after surgery.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-01-27
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-02-01
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 545

Inclusion Criteria

• Diagnosed with breast cancer
• 18 years or older

Exclusion Criteria

• unable to give written consent
• unable to understand Danish
• Previous cosmetic surgery in the breast
• Previous surgery in ipsilateral breast
• Bilateral cancer
• Concomitant corrective surgery on contralateral side
• Pregnant
• Other disease or injury in the nervous system
• Psychiatric disease
• Alcohol or drug abuse

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk factors predisposing for persistent pain after breast cancer treatment	12 months postoperative	Pre-, intra- and postoperative risk factors predisposing for persistent pain

Secondary Outcome Measures

Name	Time	Method
Prevalence of persistent pain after breast cancer treatment	12 months postoperative
Prevalence of sensory disturbances after breast cancer treatment	12 months
Acute pain after surgery for breast cancer	1 week postoperative	Prevalence of acute pain 1 week after surgery for breast cancer.
Correlation of persistent pain after breast cancer treatment and damage of the intercostobrachial nerve	12 months
Quantitative sensory testing: profile and correlation to persistent pain, sensory disturbances, signs of neuropathic pain, and treatment related factors	12 months
QST profile 1 week after surgery for breast cancer	1 week postoperative	Detailed QST profile 1 week after surgery for breast cancer. Patients will be assessed with sensory mapping, followed by assessment of mechanical and thermal thresholds.
Genetic markers and the development of persistent pain after breast cancer treatment	12 months postoperative
Test-Retest of QST after breast cancer treatment	12 months postoperative	A test-retest series of a subgroup of patients assessed with QST, to evaluate methodological reliability. Patients are scheduled to 2 QST assessments with a week between.

Trial Locations

Locations (1)

Rigshospitalet, Copenhagen University Hospital; 🇩🇰 Copenhagen, Denmark