Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer

NCT02487524 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2024-07-03

No results posted yet for this study

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).

Conditions

Interventions

OTHER

Cold 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.

OTHER

Autonomic nervous system monitoring

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

OTHER

QST

Quantitative sensory testing.

Sponsors & Collaborators

  • deCODE genetics

    collaborator INDUSTRY
  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Eija Kalso, MD, PhD · Helsinki University Central Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-28
Primary Completion
2016-04-22
Completion
2016-04-22

Countries

  • Finland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02487524 on ClinicalTrials.gov