Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer

July 1, 2024 updated by: Hanna Harno, Helsinki University Central Hospital
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

402

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • HUS
      • Helsinki, HUS, Finland, 00029
        • Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Nerve resection with pain
Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.
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.
Other: Nerve resection without pain
Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.
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.
Other: No nerve resection but pain
Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite factors related to the persistence of pain after nerve injury
Time Frame: 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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Collaborators

deCODE genetics

Investigators

  • Study Director: Eija Kalso, MD, PhD, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2014

Primary Completion (Actual)

April 22, 2016

Study Completion (Actual)

April 22, 2016

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

June 29, 2015

First Posted (Estimated)

July 1, 2015

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

July 1, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 149/13/03/00/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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