Skip to content

Neuropathic Pain After Breast Surgery

DOLORISK: Understanding Risk Factors and Determinants for Neuropathic Pain - Neuropathic Pain After Breast Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03124511
Enrollment
150
Registered
2017-04-21
Start date
2017-08-15
Completion date
2021-08-01
Last updated
2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Chemotherapy-induced Neuropathic Pain, Chronic Chemotherapy-induced Pain, Chronic Chemotherapy-induced Peripheral Neuropathy, Chronic Neuropathic Pain, Postoperative, Chronic Pain, Postoperative

Brief summary

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.

Interventions

Breast cancer resection performed via lumpectomy or mastectomy with or without sentinal node biopsy and axillary lymph node dissection.

Sponsors

DOLORisk Consortium
CollaboratorOTHER
Aarhus University Hospital
CollaboratorOTHER
Danish Pain Research Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Chronic neuropathic pain, postoperative12 months after surgeryNeuropathic pain grading system; Finnerup et al. 2016 will be used.

Secondary

MeasureTime frameDescription
Chronic chemotherapy-induced peripheral neuropathy12 months after surgeryFor case definition of neuropathy Tesfaye et al. 2010 will be used.
Chronic chemotherapy-induced neuropathic pain12 months after surgeryNeuropathic pain grading system; Finnerup et al. 2016 will be used.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026