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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer, Persistent Pain, Lymphedema, Neuropathic Pain, Neuropathy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer patients<br>Female breast cancer patients without metastasis and locally advanced disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors predisposing for persistent pain after breast cancer treatment | Pre-, intra- and postoperative risk factors predisposing for persistent pain | 12 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of persistent pain after breast cancer treatment |  | 12 months postoperative | 
| Prevalence of sensory disturbances after breast cancer treatment |  | 12 months | 
| 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 | 
| Genetic markers and the development of persistent pain after breast cancer treatment |  | 12 months postoperative | 
| QST profile 1 week after surgery for breast cancer | 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. | 1 week postoperative | 
| Acute pain after surgery for breast cancer | Prevalence of acute pain 1 week after surgery for breast cancer. | 1 week postoperative | 
| Test-Retest of QST after breast cancer treatment | 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. | 12 months postoperative |