Neuropathic Pain After Breast Surgery

NCT ID: NCT03124511

Last Updated: 2021-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-15

Study Completion Date

2021-08-01

Brief Summary

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

Detailed Description

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Surgery for breast cancer

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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DOLORisk Consortium

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

Danish Pain Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nanna B Finnerup, DMSc

Role: STUDY_DIRECTOR

Danish Pain Research Center, Aarhus University

Locations

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Danish Pain Research Center, Aarhus University Hospital

Aarhus C, , Denmark

Site Status

Breast Surgery Clinic, Viborg Regional Hospital

Viborg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 20876709 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27115670 (View on PubMed)

Related Links

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http://www.dolorisk.eu

DOLORisk Project Website

Other Identifiers

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DOLORISK-BREAST

Identifier Type: -

Identifier Source: org_study_id

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