Study of Lipid Mediators in Chronic Postoperative Pain - LICP

Not Applicable

Recruiting

• Conditions: Breast Cancer Female; Postoperative Pain

• Registration Number: NCT06907810
• Lead Sponsor: Université Catholique de Louvain

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-11
• Study Start: 2025-03-12
• Study First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-02
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain intensity	Throughout the study, an average of 2 years	Pain intensity will be evaluated using a standardized questionnaire completed by participants at each medical consultation.
Pain duration	Throughout the study, an average of 2 years	Pain duration will be evaluated using a standardized questionnaire completed by participants at each medical consultation.
Lipid Mediator Levels in Blood	Throughout the study, an average of 2 years	Lipid mediator levels will be quantified in blood samples by LC-MS methods

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc (UCLouvain); 🇧🇪 Brussels, Belgium