NCT02487524

Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 402 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Neuropathic Pain
• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-10-28
• Primary completion: 2016-04-22
• Completion: 2016-04-22
• First posted: 2015-07-01
• Last updated: 2024-07-03

Locations

1 site across 1 country: Finland