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Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer

Primary Purpose

Neuropathic Pain, Breast Cancer

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Cold water test
Autonomic nervous system monitoring
QST
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neuropathic Pain focused on measuring Neuropathic Pain, Breast Cancer, Post surgical

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Helsinki University Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Nerve resection with pain

Nerve resection without pain

No nerve resection but pain

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 25, 2015
Last Updated
May 29, 2023
Sponsor
Helsinki University Central Hospital
Collaborators
deCODE genetics
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1. Study Identification

Unique Protocol Identification Number
NCT02487524
Brief Title
Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer
Official Title
Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 28, 2014 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
deCODE genetics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Breast Cancer
Keywords
Neuropathic Pain, Breast Cancer, Post surgical

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
402 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nerve resection with pain
Arm Type
Other
Arm Description
Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.
Arm Title
Nerve resection without pain
Arm Type
Other
Arm Description
Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.
Arm Title
No nerve resection but pain
Arm Type
Other
Arm Description
Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST.
Intervention Type
Other
Intervention Name(s)
Cold water test
Intervention Description
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
Intervention Name(s)
Autonomic nervous system monitoring
Intervention Description
The autonomic nervous system is monitored during the cold water test and 15 minutes thereafter.
Intervention Type
Other
Intervention Name(s)
QST
Intervention Description
Quantitative sensory testing.
Primary Outcome Measure Information:
Title
Composite factors related to the persistence of pain after nerve injury
Description
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.
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eija Kalso, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
State/Province
HUS
ZIP/Postal Code
00029
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.
Citations:
PubMed Identifier
24343286
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.
Results Reference
background
PubMed Identifier
24381969
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.
Results Reference
background
PubMed Identifier
20851519
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.
Results Reference
background
PubMed Identifier
25575710
Citation
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.
Results Reference
background
PubMed Identifier
35139264
Citation
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.
Results Reference
derived
PubMed Identifier
34087967
Citation
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.
Results Reference
derived
PubMed Identifier
33725747
Citation
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.
Results Reference
derived

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Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer

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