Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer

NCT02487524 | Completed

• 1 other identifier: 149/13/03/00/14
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Neuropathic Pain; Breast Cancer

Keywords

Neuropathic Pain; Breast Cancer; Post surgical

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Nerve resection with pain

OTHER

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

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

Nerve resection without pain

OTHER

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

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

No nerve resection but pain

OTHER

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

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

Interventions

Cold water test 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.

Nerve resection with pain; Nerve resection without pain; No nerve resection but pain

Autonomic nervous system monitoring OTHER

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

Nerve resection with pain; Nerve resection without pain; No nerve resection but pain

QST OTHER

Quantitative sensory testing.

Nerve resection with pain; Nerve resection without pain; No nerve resection but pain

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• age over 75 years
• living far away from study site

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• deCODE genetics: collaborator

Study Sites (1)

Helsinki University Central Hospital

Helsinki, HUS, 00029, Finland

Location

Related Publications (7)

• 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.

  PMID: 24343286 BACKGROUND

• 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.

  PMID: 24381969 BACKGROUND

• 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.

  PMID: 20851519 BACKGROUND

• 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.

  PMID: 25575710 BACKGROUND

• Aho T, Sipila R, Kalso E, Harno H. Temperament and character dimensions differ in chronic post-surgical neuropathic pain and cold pressure pain. Scand J Pain. 2022 Feb 9;22(3):515-525. doi: 10.1515/sjpain-2021-0163. Print 2022 Jul 26.

  PMID: 35139264 DERIVED

• Honkanen N, Mustonen L, Kalso E, Meretoja T, Harno H. Breast reconstruction after breast cancer surgery - persistent pain and quality of life 1-8 years after breast reconstruction. Scand J Pain. 2021 Jun 7;21(3):522-529. doi: 10.1515/sjpain-2021-0026. Print 2021 Jul 27.

  PMID: 34087967 DERIVED

• Sipila R, Kemp H, Harno H, Rice ASC, Kalso E. Health-related quality of life and pain interference in two patient cohorts with neuropathic pain: breast cancer survivors and HIV patients. Scand J Pain. 2021 Mar 17;21(3):512-521. doi: 10.1515/sjpain-2020-0177. Print 2021 Jul 27.

  PMID: 33725747 DERIVED

MeSH Terms

Conditions

Neuralgia; Breast Neoplasms

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Eija Kalso, MD, PhD

  Helsinki University Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: July 1, 2015
• Study Start: October 28, 2014
• Primary Completion: April 22, 2016
• Study Completion: April 22, 2016
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)