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Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer

Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02487524
Enrollment
402
Registered
2015-07-01
Start date
2014-10-28
Completion date
2016-04-22
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic Pain, Breast Cancer

Keywords

Neuropathic Pain, Breast Cancer, Post surgical

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.

Interventions

OTHERCold water test

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.

The autonomic nervous system is monitored during the cold water test and 15 minutes thereafter.

OTHERQST

Quantitative sensory testing.

Sponsors

deCODE genetics
CollaboratorINDUSTRY
Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Composite factors related to the persistence of pain after nerve injury5 yearsStudy 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.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026