Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-28

Study Completion Date

2016-04-22

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Neuropathic Pain Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Nerve resection with pain

Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.

Group Type OTHER

Cold water test

Intervention Type OTHER

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

Intervention Type OTHER

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

QST

Intervention Type OTHER

Quantitative sensory testing.

Nerve resection without pain

Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.

Group Type OTHER

Cold water test

Intervention Type OTHER

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

Intervention Type OTHER

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

QST

Intervention Type OTHER

Quantitative sensory testing.

No nerve resection but pain

Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.

Group Type OTHER

Cold water test

Intervention Type OTHER

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

Intervention Type OTHER

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

QST

Intervention Type OTHER

Quantitative sensory testing.

Interventions

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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.

Intervention Type OTHER

Autonomic nervous system monitoring

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

Intervention Type OTHER

QST

Quantitative sensory testing.

Intervention Type OTHER

Eligibility Criteria

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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