Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 545
- Locations
- 1
- Primary Endpoint
- Risk factors predisposing for persistent pain after breast cancer treatment
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Kenneth Geving Andersen
Physician, research fellow
Rigshospitalet, Denmark
Eligibility Criteria
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
- •Other disease or injury in the nervous system
- •Psychiatric disease
- •Alcohol or drug abuse
Outcomes
Primary Outcomes
Risk factors predisposing for persistent pain after breast cancer treatment
Time Frame: 12 months postoperative
Pre-, intra- and postoperative risk factors predisposing for persistent pain
Secondary Outcomes
- 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)
- 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)
- 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)