Neuropathic Pain After Breast Surgery

Overview

To understand pain pathophysiology in terms of risk factors and protective mechanisms ranging from molecular pathways to societal impacts.

Full Title of Study: “DOLORISK: Understanding Risk Factors and Determinants for Neuropathic Pain – Neuropathic Pain After Breast Surgery”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 1, 2021

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

  • Procedure: Surgery for breast cancer
    • Breast cancer resection performed via lumpectomy or mastectomy with or without sentinal node biopsy and axillary lymph node dissection.

Clinical Trial Outcome Measures

Primary Measures

  • Chronic neuropathic pain, postoperative
    • Time Frame: 12 months after surgery
    • Neuropathic pain grading system; Finnerup et al. 2016 will be used.

Secondary Measures

  • Chronic chemotherapy-induced peripheral neuropathy
    • Time Frame: 12 months after surgery
    • For case definition of neuropathy Tesfaye et al. 2010 will be used.
  • Chronic chemotherapy-induced neuropathic pain
    • Time Frame: 12 months after surgery
    • Neuropathic pain grading system; Finnerup et al. 2016 will be used.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Danish Pain Research Center
  • Collaborator
    • DOLORisk Consortium
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nanna B Finnerup, DMSc, Study Director, Danish Pain Research Center, Aarhus University

References

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. Erratum In: Diabetes Care. 2010 Dec;33(12):2725.

Finnerup 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.

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