Chronic Neuropathic Pain, PostoperativeNCT03124511
Neuropathic Pain After Breast Surgery
An observational study of Chronic Neuropathic Pain, Postoperative and Chronic Pain, Postoperative, run by Danish Pain Research Center at 2 sites in Denmark.
Trial summary
To understand pain pathophysiology in terms of risk factors and protective mechanisms ranging from molecular pathways to societal impacts. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Chronic Neuropathic Pain, Postoperative, Chronic Pain, Postoperative, Chronic Chemotherapy-induced Neuropathic Pain
- What is being tested?
- Surgery for breast cancer
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 2 sitesDenmark
- Study dates
- 15 Aug 2017to 1 Aug 2021
- Phase
- Observational
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for breast cancer resection at the Department of Breast Surgery, Aarhus University Hospital, Aarhus, and the Breast Surgery Clinic, Viborg Regional Hospital, Viborg, Denmark.
Who may be able to join
- Patients scheduled for breast cancer resection performed via lumpectomy (partial or segmental mastectomy) or mastectomy with or without sentinel lymph node biopsy and axillary lymph node dissection, and any combinations hereof.
- Willingness and ability to comply with study procedures as judged by the site investigator/manager.
- Expected availability for follow-up throughout the study, i.e., ~12 months.
- Willingness to voluntarily sign and date the study-specific informed consent form.
Who cannot join
- Mental incapacity or language barriers precluding adequate understanding of study procedures.
- Current alcohol or substance abuse according to the site investigator's medical judgement.
- Unsuitability for participation in the study for any other reason, e.g. due to a significant serious underlying condition (e.g. other cancer or AIDS), as determined by the site investigator/manager.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Danish Pain Research Center, Aarhus University Hospital
Aarhus C, 8000
Breast Surgery Clinic, Viborg Regional Hospital
Viborg, 8800
About this study
Official title: DOLORISK: Understanding Risk Factors and Determinants for Neuropathic Pain - Neuropathic Pain After Breast Surgery
To understand pain pathophysiology in terms of risk factors and protective mechanisms ranging from molecular pathways to societal impacts.
Read the detailed description
Pain and loss of function are intimately associated with the reaction of the nervous system to neural damage. A lesion to the somatosensory nervous system caused by mechanical trauma, metabolic disease, neurotoxic chemicals, infection or tumor invasion may give rise to neuropathic pain. Neuropathic pain affects around 8% of the population and may negatively impact the individual's quality of life; moreover, the condition leads to significant costs to the healthcare system and society. Not all subjects with such a lesion develop neuropathic pain, and those who do develop neuropathic pain have varying degrees of symptom severity, impact and outcomes and may respond unpredictably to treatment.
The interaction between genetics and environmental and clinical factors in a susceptible individual most likely contribute to the variation in pain prevalence and severity. A better understanding of the exact nature of these risk factors and their interactions will ultimately improve the patients' health, both in terms of recognizing patients at risk and identifying new treatment modalities.
Genetic, neurophysiological and psychological factors all influence the risk of developing persistent pain. It is therefore possible to describe a genetic, neurophysiological and psychological profile, in particular in patients experiencing neuropathic pain after surgery and/or neurotoxic chemotherapy.
- Conditions
- Chronic Neuropathic Pain, Postoperative, Chronic Pain, Postoperative, Chronic Chemotherapy-induced Neuropathic Pain, Chronic Chemotherapy-induced Pain, Chronic Chemotherapy-induced Peripheral Neuropathy
- Being tested
- Surgery for breast cancer
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for breast cancerProcedure or surgery
Breast cancer resection performed via lumpectomy or mastectomy with or without sentinal node biopsy and axillary lymph node dissection.
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic neuropathic pain, postoperative
Neuropathic pain grading system; Finnerup et al. 2016 will be used.
Measured: 12 months after surgery
Secondary outcomes (2)
Chronic chemotherapy-induced peripheral neuropathy
For case definition of neuropathy Tesfaye et al. 2010 will be used.
Measured: 12 months after surgery
Chronic chemotherapy-induced neuropathic pain
Neuropathic pain grading system; Finnerup et al. 2016 will be used.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start15 Aug 2017
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Neuropathic Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Pain Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- DOLORisk Consortium, Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Nanna B Finnerup, DMSc, Study director, Danish Pain Research Center, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124511
- Sponsor's protocol ID
- DOLORISK-BREAST
- Status last verified
- Aug 2021
- First submitted
- 19 Apr 2017
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303.
PubMed 20876709Finnerup NB, Haroutounian S, Kamerman P, Baron R, Bennett DLH, Bouhassira D, Cruccu G, Freeman R, Hansson P, Nurmikko T, Raja SN, Rice ASC, Serra J, Smith BH, Treede RD, Jensen TS. Neuropathic pain: an updated grading system for research and clinical practice. Pain. 2016 Aug;157(8):1599-1606. doi: 10.1097/j.pain.0000000000000492.
PubMed 27115670Sperandio G, Baudic S, Bennedsgaard K, Grosen K, Andersen IS, Finnerup NB, Albi-Feldzer A, Flor H, Nees F, Bouhassira D, Attal N. Somatic and psychological predictors of chronic postsurgical pain in cancer patients: a machine learning approach in a longitudinal two-centre study. Br J Anaesth. 2026 Apr;136(4):1330-1340. doi: 10.1016/j.bja.2025.12.002. Epub 2026 Jan 7.
PubMed 41506969
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DOLORISK: Understanding Risk Factors and Determinants for Neuropathic Pain - Neuropathic Pain After Breast Surgery
- ClinicalTrials.gov ID
- NCT03124511
- Acronym / sponsor ID
- DOLORISK-BREAST
- Conditions
- Chronic Neuropathic Pain, Postoperative, Chronic Pain, Postoperative, Chronic Chemotherapy-induced Neuropathic Pain, Chronic Chemotherapy-induced Pain, Chronic Chemotherapy-induced Peripheral Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Danish Pain Research CenterUniversity, hospital or other
- Collaborators
- DOLORisk Consortium, Aarhus University Hospital
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 21 Apr 2017 (actual)
- 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.
To understand pain pathophysiology in terms of risk factors and protective mechanisms ranging from molecular pathways to societal impacts.
Detailed description
Pain and loss of function are intimately associated with the reaction of the nervous system to neural damage. A lesion to the somatosensory nervous system caused by mechanical trauma, metabolic disease, neurotoxic chemicals, infection or tumor invasion may give rise to neuropathic pain. Neuropathic pain affects around 8% of the population and may negatively impact the individual's quality of life; moreover, the condition leads to significant costs to the healthcare system and society. Not all subjects with such a lesion develop neuropathic pain, and those who do develop neuropathic pain have varying degrees of symptom severity, impact and outcomes and may respond unpredictably to treatment.
The interaction between genetics and environmental and clinical factors in a susceptible individual most likely contribute to the variation in pain prevalence and severity. A better understanding of the exact nature of these risk factors and their interactions will ultimately improve the patients' health, both in terms of recognizing patients at risk and identifying new treatment modalities.
Genetic, neurophysiological and psychological factors all influence the risk of developing persistent pain. It is therefore possible to describe a genetic, neurophysiological and psychological profile, in particular in patients experiencing neuropathic pain after surgery and/or neurotoxic chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for breast cancer resection at the Department of Breast Surgery, Aarhus University Hospital, Aarhus, and the Breast Surgery Clinic, Viborg Regional Hospital, Viborg, Denmark.
Key inclusion criteria (4 listed)
- Patients scheduled for breast cancer resection performed via lumpectomy (partial or segmental mastectomy) or mastectomy with or without sentinel lymph node biopsy and axillary lymph node dissection, and any combinations hereof.
- Willingness and ability to comply with study procedures as judged by the site investigator/manager.
- Expected availability for follow-up throughout the study, i.e., ~12 months.
- Willingness to voluntarily sign and date the study-specific informed consent form.
Key exclusion criteria (3 listed)
- Mental incapacity or language barriers precluding adequate understanding of study procedures.
- Current alcohol or substance abuse according to the site investigator's medical judgement.
- Unsuitability for participation in the study for any other reason, e.g. due to a significant serious underlying condition (e.g. other cancer or AIDS), as determined by the site investigator/manager.
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 |
|---|---|---|
| Surgery for breast cancerBreast cancer resection performed via lumpectomy or mastectomy with or without sentinal node biopsy and axillary lymph node dissection. | Procedure or surgery | – |
Primary outcome
Chronic neuropathic pain, postoperative
Time frame: 12 months after surgery
Neuropathic pain grading system; Finnerup et al. 2016 will be used.
2 secondary outcomes
Chronic chemotherapy-induced peripheral neuropathy
Time frame: 12 months after surgery
Chronic chemotherapy-induced neuropathic pain
Time frame: 12 months after surgery
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 17 Aug 2021.
- Background: PubMed 20876709Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303.
- Background: PubMed 27115670Finnerup NB, Haroutounian S, Kamerman P, Baron R, Bennett DLH, Bouhassira D, Cruccu G, Freeman R, Hansson P, Nurmikko T, Raja SN, Rice ASC, Serra J, Smith BH, Treede RD, Jensen TS. Neuropathic pain: an updated grading system for research and clinical practice. Pain. 2016 Aug;157(8):1599-1606. doi: 10.1097/j.pain.0000000000000492.
- Derived from this study: PubMed 41506969Sperandio G, Baudic S, Bennedsgaard K, Grosen K, Andersen IS, Finnerup NB, Albi-Feldzer A, Flor H, Nees F, Bouhassira D, Attal N. Somatic and psychological predictors of chronic postsurgical pain in cancer patients: a machine learning approach in a longitudinal two-centre study. Br J Anaesth. 2026 Apr;136(4):1330-1340. doi: 10.1016/j.bja.2025.12.002. Epub 2026 Jan 7.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Neuropathic Pain, Postoperative
Recruiting
Comparison of Two Postoperative Care Strategies After Breast Surgery
Postoperative Pain, Pain Management
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Recruiting
Intraoperative Lidocaine or Dexmedetomidine for Postoperative Pain Modulation After Urethral Reconstruction.
Urethral Stricture
Recruiting
Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain
Spinal Cord Injuries, Nerve Injury
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
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.
Nanna B Finnerup, DMSc study director
Danish Pain Research Center, Aarhus University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Neuropathic Pain, Postoperative and Chronic Pain, Postoperative, run by Danish Pain Research Center at 2 sites in Denmark.
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 4 inclusion and 3 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 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Chronic neuropathic pain, postoperative (time frame: 12 months after surgery). 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 NCT03124511, which also lists 3 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 17 Aug 2021.