Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer

Not Applicable

Completed

• Conditions: Neuropathic Pain; Breast Cancer
• Interventions: Other: Cold water test; Other: Autonomic nervous system monitoring; Other: QST

• Registration Number: NCT02487524
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-10-28
• Study First Submitted: 2015-06-25
• Study First Submitted QC: 2015-06-29
• Study First Posted: 2015-07-01
• Primary Completion: 2016-04-22
• Study Completion: 2016-04-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 402

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No nerve resection but pain	QST	Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.
No nerve resection but pain	Autonomic nervous system monitoring	Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.
Nerve resection without pain	Autonomic nervous system monitoring	Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.
No nerve resection but pain	Cold water test	Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.
Nerve resection with pain	QST	Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.
Nerve resection without pain	Cold water test	Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.
Nerve resection without pain	QST	Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.
Nerve resection with pain	Cold water test	Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.
Nerve resection with pain	Autonomic nervous system monitoring	Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.

Primary Outcome Measures

Name	Time	Method
Composite factors related to the persistence of pain after nerve injury	5 years	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.

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, HUS, Finland