Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer

Breast Cancer Clinical Trial

Official title:

Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02487524
• Other study ID #: 149/13/03/00/14
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 28, 2014
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 402
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neuralgia
• Neuropathic Pain

Intervention

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.
• Autonomic nervous system monitoring
The autonomic nervous system is monitored during the cold water test and 15 minutes thereafter.
• QST
Quantitative sensory testing.

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki	HUS

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	deCODE genetics

Country where clinical trial is conducted

Finland, 

References & Publications (4)

Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, Gilron I, Haanpaa M, Hansson P, Jensen TS, Kamerman PR, Lund K, Moore A, Raja SN, Rice AS, Rowbotham M, Sena E, Siddall P, Smith BH, Wallace M. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162-73. doi: 10.1016/S1474-4422(14)70251-0. Epub 2015 Jan 7. — View Citation

Haanpaa M, Attal N, Backonja M, Baron R, Bennett M, Bouhassira D, Cruccu G, Hansson P, Haythornthwaite JA, Iannetti GD, Jensen TS, Kauppila T, Nurmikko TJ, Rice ASC, Rowbotham M, Serra J, Sommer C, Smith BH, Treede RD. NeuPSIG guidelines on neuropathic pain assessment. Pain. 2011 Jan;152(1):14-27. doi: 10.1016/j.pain.2010.07.031. Epub 2010 Sep 19. — View Citation

Kaunisto MA, Jokela R, Tallgren M, Kambur O, Tikkanen E, Tasmuth T, Sipila R, Palotie A, Estlander AM, Leidenius M, Ripatti S, Kalso EA. Pain in 1,000 women treated for breast cancer: a prospective study of pain sensitivity and postoperative pain. Anesthesiology. 2013 Dec;119(6):1410-21. doi: 10.1097/ALN.0000000000000012. — View Citation

Meretoja TJ, Leidenius MHK, Tasmuth T, Sipila R, Kalso E. Pain at 12 months after surgery for breast cancer. JAMA. 2014 Jan 1;311(1):90-92. doi: 10.1001/jama.2013.278795. No abstract available. Erratum In: JAMA. 2017 Apr 25;317(16):1693. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite factors related to the persistence of pain after nerve injury	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