Neuropathic PainNCT02487524
Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer
A study testing Cold water test, Autonomic nervous system monitoring and QST in people with Neuropathic Pain and Breast Cancer, run by Helsinki University Central Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Neuropathic Pain, Breast Cancer
- What is being tested?
- Cold water test, Autonomic nervous system monitoring and QST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 1 siteFinland
- Study dates
- 28 Oct 2014to 22 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- age over 75 years
- living far away from study site
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Being tested
- Cold water test, Autonomic nervous system monitoring, QST
- Keywords
- Neuropathic Pain, Breast Cancer, Post surgical
- Medical subject headings
- Neuralgia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold water testOther
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 monitoringOther
The autonomic nervous system is monitored during the cold water test and 15 minutes thereafter.
QSTOther
Quantitative sensory testing.
| Study group | Role | What they receive |
|---|---|---|
| Nerve resection with pain | Other | Questionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST. Receives: 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. Receives: 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. Receives: Other: Cold water test; Other: Autonomic nervous system monitoring; Other: QST |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study start28 Oct 2014
- Primary completion22 Apr 2016
- Study completion22 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- deCODE genetics
- Responsible party
- Principal investigator, Hanna Harno, Helsinki University Central Hospital
- Investigators
- Eija Kalso, MD, PhD, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487524
- Sponsor's protocol ID
- 149/13/03/00/14
- Status last verified
- Jul 2024
- First submitted
- 25 Jun 2015
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
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.
PubMed 24343286Meretoja 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.
PubMed 24381969Haanpaa 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.
PubMed 20851519Finnerup 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.
PubMed 25575710Aho 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.
PubMed 35139264Honkanen 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.
PubMed 34087967Sipila 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.
PubMed 33725747
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Neuropathic Pain in Women Treated for Breast Cancer
- ClinicalTrials.gov ID
- NCT02487524
- Acronym / sponsor ID
- 149/13/03/00/14
- Conditions
- Neuropathic Pain, Breast Cancer
- Keywords
- Neuropathic Pain, Breast Cancer, Post surgical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- deCODE genetics
- Study start
- 28 Oct 2014 (actual)
- Primary completion
- 22 Apr 2016 (actual)
- Study completion
- 22 Apr 2016 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nerve resection with pain | Other | Other: Cold water test, Other: Autonomic nervous system monitoring, Other: QSTQuestionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST. |
| Nerve resection without pain | Other | Other: Cold water test, Other: Autonomic nervous system monitoring, Other: QSTQuestionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST. |
| No nerve resection but pain | Other | Other: Cold water test, Other: Autonomic nervous system monitoring, Other: QSTQuestionnaires, cognitive tests, sensory examination, cold water test with autonomic nervous system monitoring. QST. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- age over 75 years
- living far away from study site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold water testThe 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 | Nerve resection with pain, Nerve resection without pain, No nerve resection but pain |
| Autonomic nervous system monitoringThe autonomic nervous system is monitored during the cold water test and 15 minutes thereafter. | Other | Nerve resection with pain, Nerve resection without pain, No nerve resection but pain |
| QSTQuantitative sensory testing. | Other | Nerve resection with pain, Nerve resection without pain, No nerve resection but pain |
Primary outcome
Composite factors related to the persistence of pain after nerve injury
Time frame: 5 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 24343286Kaunisto 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.
- Background: PubMed 24381969Meretoja 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.
- Background: PubMed 20851519Haanpaa 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.
- Background: PubMed 25575710Finnerup 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.
- Derived from this study: PubMed 35139264Aho 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.
- Derived from this study: PubMed 34087967Honkanen 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.
- Derived from this study: PubMed 33725747Sipila 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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eija Kalso, MD, PhD study director
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold water test, Autonomic nervous system monitoring and QST in people with Neuropathic Pain and Breast Cancer, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite factors related to the persistence of pain after nerve injury (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02487524, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.