Neuropathic Pain After Breast Surgery

Chronic Chemotherapy-induced Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03124511
• Other study ID #: DOLORISK-BREAST
• Status: Completed
• Start date: August 15, 2017
• Est. completion date: August 1, 2021

Study information

• Verified date: August 2021
• Source: Danish Pain Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Chemotherapy-induced Neuropathic Pain
• Chronic Chemotherapy-induced Pain
• Chronic Chemotherapy-induced Peripheral Neuropathy
• Chronic Neuropathic Pain, Postoperative
• Chronic Pain
• Chronic Pain, Postoperative
• Neuralgia
• Pain, Postoperative
• Peripheral Nervous System Diseases

Intervention

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

Locations

Country	Name	City	State
Denmark	Danish Pain Research Center, Aarhus University Hospital	Aarhus C
Denmark	Breast Surgery Clinic, Viborg Regional Hospital	Viborg

Sponsors (3)

Lead Sponsor	Collaborator
Danish Pain Research Center	Aarhus University Hospital, DOLORisk Consortium

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. Review. — View Citation

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. Review. Erratum in: Diabetes Care. 2010 Dec;33(12):2725. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic neuropathic pain, postoperative	Neuropathic pain grading system; Finnerup et al. 2016 will be used.	12 months after surgery
Secondary	Chronic chemotherapy-induced peripheral neuropathy	For case definition of neuropathy Tesfaye et al. 2010 will be used.	12 months after surgery
Secondary	Chronic chemotherapy-induced neuropathic pain	Neuropathic pain grading system; Finnerup et al. 2016 will be used.	12 months after surgery

External Links

•   DOLORisk Project Website