Overview

This trial is active, not recruiting.

Conditions neuropathic pain, breast cancer
Treatments cold water test, autonomic nervous system monitoring, qst
Sponsor Helsinki University Central Hospital
Collaborator deCODE genetics
Start date October 2014
End date December 2018
Trial size 402 participants
Trial identifier NCT02487524, 149/13/03/00/14

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking single blind (investigator)
Arm
(Other)
Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.
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.
autonomic nervous system monitoring
The autonomic nervous system is monitored during the cold water test and 15 minutes thereafter.
qst
Quantitative sensory testing.
(Other)
Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.
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.
autonomic nervous system monitoring
The autonomic nervous system is monitored during the cold water test and 15 minutes thereafter.
qst
Quantitative sensory testing.
(Other)
Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.
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.
autonomic nervous system monitoring
The autonomic nervous system is monitored during the cold water test and 15 minutes thereafter.
qst
Quantitative sensory testing.

Primary Outcomes

Measure
Composite factors related to the persistence of pain after nerve injury
time frame: 5 years

Eligibility Criteria

Female participants from 18 years up to 75 years old.

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

Additional Information

Official title Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Helsinki University Central Hospital.