Neuropathic Pain After Breast Surgery

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.

Study Overview

• Status: Completed
• Conditions: Chronic Neuropathic Pain, Postoperative; Chronic Pain, Postoperative; Chronic Chemotherapy-induced Neuropathic Pain; Chronic Chemotherapy-induced Pain; Chronic Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: Procedure: Surgery for breast cancer

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 Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C, Denmark, 8000
    • Danish Pain Research Center, Aarhus University Hospital
  • Viborg, Denmark, 8800
    • Breast Surgery Clinic, Viborg Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Danish Pain Research Center
• Collaborators: DOLORisk Consortium; Aarhus University Hospital

Publications and helpful links

General 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. 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.

Helpful Links

• DOLORisk Project Website

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 15, 2017
• Primary Completion (ACTUAL): August 1, 2021
• Study Completion (ACTUAL): August 1, 2021

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (ACTUAL): April 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neuromuscular Diseases; Pain, Postoperative; Chronic Pain; Neuralgia; Peripheral Nervous System Diseases
• Other Study ID Numbers: DOLORISK-BREAST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No