Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer

Study Overview
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Brief Summary
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Investigators aim to identify the key phenotypes (biological, psychological, genetic) involved in the transition from acute to chronic neuropathic pain (NP) by comparison of the neuropathic pain phenotypes and genomics of patients developing NP or not under similar nerve injury conditions. The cohort is part of a previous prospective study of 1000 patients operated for breast cancer of whom 350 have surgeon defined intercostobrachial nerve resection during operation with or without persistent pain and additional 50 patients with pain, but no nerve resection during operation. Patients fill in questionnaires and a detailed sensory examination, cognitive tests, and a cold water test with autonomic nervous system monitoring are performed during the research visit. A selected group of patients undergo quantitative sensory testing (QST).

Detailed Description
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This cohort is part of a previous prospective study of 1000 breast cancer operated women. Of these, there are 350 patients with surgeon defined intercostobrachial nerve resection during the operation. Part of the patients have pain, part of them are pain free. In addition the investigators plan to enroll 50 patients with pain, but no nerve resection during operation. The patients come for a clinical research visit. Beforehand they fill in questionnaires of medical history, pain, mood, temperament, quality of life, and sleeping. After informed consent the patients give a blood sample with prior 12 hour fasting. The investigators present a detailed sensory testing with body maps and patient pain drawings. The investigators perform a cold water test with autonomic nervous system monitoring and conduct a set of cognitive tests, part of them computer based. A selected group of patients undergo QST.

Official Title
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Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer

Conditions
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Neuropathic Pain, Breast Cancer

Intervention / Treatment
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* Other: Cold water test
* Other: Autonomic nervous system monitoring
* Other: QST


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: belongs to the cohort of 1000 breast cancer operated women and has had nerve resection during the operation (with or without pain) or no nerve resection, but pain sufficient Finnish language skills Exclusion Criteria: age over 75 years living far away from study site

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nerve resection with pain<br>Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST. | Other: Cold water test<br>* The patients immerse their hand into cold water for a maximum of 90 seconds and report their pain intensity every 15 seconds during the test.<br>Other: Autonomic nervous system monitoring<br>* The autonomic nervous system is monitored during the cold water test and 15 minutes thereafter.<br>Other: QST<br>* Quantitative sensory testing.<br>|
| Other: Nerve resection without pain<br>Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST. | Other: Cold water test<br>* The patients immerse their hand into cold water for a maximum of 90 seconds and report their pain intensity every 15 seconds during the test.<br>Other: Autonomic nervous system monitoring<br>* The autonomic nervous system is monitored during the cold water test and 15 minutes thereafter.<br>Other: QST<br>* Quantitative sensory testing.<br>|
| Other: No nerve resection but pain<br>Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST. | Other: Cold water test<br>* The patients immerse their hand into cold water for a maximum of 90 seconds and report their pain intensity every 15 seconds during the test.<br>Other: Autonomic nervous system monitoring<br>* The autonomic nervous system is monitored during the cold water test and 15 minutes thereafter.<br>Other: QST<br>* Quantitative sensory testing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite factors related to the persistence of pain after nerve injury | Study of associations between phenotypic and genotypic data. Phenotyping is assessed by detailed sensory testing, questionnaires related to pain (Brief Pain Inventory, Numeric Rating Scale), psychological factors (Pain Catastrophizing Scale, Hospital Anxiety and Depression Rating Scale), personality (Ten-item Personality Inventory) and quality of life (36-item Short Form Health Survey and Insomnia Severity Index). Additionally, cognitive tests, a cold water test with autonomic nervous function monitoring, and a blood sample. DNA will be isolated from blood samples and analyzed for genetic variants associated with new neuropathic pain phenotypes. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic Pain, Breast Cancer, Post surgical