Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Breast Cancer; Neuropathic Pain

Treatments: Other: QST; Other: Cold water test; Other: Autonomic nervous system monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02487524

149/13/03/00/14

Details and patient eligibility

About

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).

Full 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.

Enrollment: 402 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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402 participants in 3 patient groups

Nerve resection with pain

Other group

Description:

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

Treatment:

Other: Autonomic nervous system monitoring

Other: Cold water test

Other: QST

Nerve resection without pain

Other group

Description:

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

Treatment:

Other: Autonomic nervous system monitoring

Other: Cold water test

Other: QST

No nerve resection but pain

Other group

Description:

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

Treatment:

Other: Autonomic nervous system monitoring

Other: Cold water test

Other: QST