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OpenTrials
Completed

NCT Number: NCT03124511

Neuropathic Pain After Breast Surgery

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

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Danish Pain Research Center, Aarhus University Hospital, Aarhus C, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgery for breast cancer

Procedure

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

Primary outcomes

  1. Chronic neuropathic pain, postoperative

    Time frame: 12 months after surgery

    Neuropathic pain grading system; Finnerup et al. 2016 will be used.

Secondary outcomes

  1. Chronic chemotherapy-induced peripheral neuropathy

    Time frame: 12 months after surgery

    For case definition of neuropathy Tesfaye et al. 2010 will be used.

  2. Chronic chemotherapy-induced neuropathic pain

    Time frame: 12 months after surgery

    Neuropathic pain grading system; Finnerup et al. 2016 will be used.

Sponsors and collaborators

Lead sponsor

Danish Pain Research Center

Other

Collaborators

  • Aarhus University Hospital
  • DOLORisk Consortium

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 21, 2017
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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