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NCT Number: NCT06907810

Study of Lipid Mediators in Chronic Postoperative Pain - LICP

This interventional prospective study aims firstly to investigate variations in lipid levels in blood samples and their potential relationship with the duration and/or intensity of post-operative pain. Secondly, it aims to investigate the activation of peripheral blood mononuclear cells and neutrophils in patient blood samples. The study will enrol women aged 18 years or older who have been newly diagnosed with primary invasive or non-invasive breast cancer requiring surgical removal of the tumour, with or without axillary surgery.

The main objectives of the study are To assess whether there is an association between circulating levels of lipid mediators and chronicity (> 3 months) of postoperative pain after breast cancer surgery.

To assess whether circulating levels of lipid mediators can predict chronicity of postoperative pain in breast cancer surgery.

To assess the existence of an association between resected tissue levels of lipid mediators and chronicity of postoperative pain in breast cancer surgery.

To assess whether tissue levels of lipid mediators can predict chronicity of postoperative pain in breast cancer surgery.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc (UCLouvain)

Brussels, Brussels Capital, 1200, Belgium

Location status: Recruiting

Location contact

Lisa Martin, MSC

CONTACT

[email protected]

0032471089309

Martine Berlière, MD, PhD

CONTACT

[email protected]

00327641075

Mireille Alhouayek, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women older than 18 years
  • Newly diagnosed primary invasive or non-invasive breast cancer, requiring surgical excision of the tumor, with or without axillary surgery
  • Able to give informed consent

Exclusion criteria

  • Men
  • Women aged less than 18 years
  • Pregnant women
  • History of major psychiatric disorders
  • Previous breast or axillary surgery, recurrent disease or detectable metastatic disease at the time of diagnosis
  • Unable to give informed consent

Treatment and study plan

Blood sample + questionnaire

Other
  • blood sample before tumor surgery and at every follow-up visit
  • questionnaire before tumor surgery and at every follow-up visit

Primary outcomes

  1. Pain intensity

    Time frame: Throughout the study, an average of 2 years

    Pain intensity will be evaluated using a standardized questionnaire completed by participants at each medical consultation.

  2. Pain duration

    Time frame: Throughout the study, an average of 2 years

    Pain duration will be evaluated using a standardized questionnaire completed by participants at each medical consultation.

  3. Lipid Mediator Levels in Blood

    Time frame: Throughout the study, an average of 2 years

    Lipid mediator levels will be quantified in blood samples by LC-MS methods

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Martin, MSC

CONTACT

[email protected]

Martine Berlière, MD, PhD

CONTACT

[email protected]

00327641075

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Registry information

Official study title

Study of Lipid Mediators in Chronic Postoperative Pain Following Breast Cancer Surgery

Acronym: LICP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 2, 2025
Registry last updated
Apr 2, 2025

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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