Study of Lipid Mediators in Chronic Postoperative Pain - LICP (LICP)

March 31, 2025 updated by: Université Catholique de Louvain

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chronic pain
Other: Blood sample + questionnaire
  • blood sample before tumor surgery and at every follow-up visit
  • questionnaire before tumor surgery and at every follow-up visit
Active Comparator: No chronic pain
Other: Blood sample + questionnaire
  • blood sample before tumor surgery and at every follow-up visit
  • questionnaire before tumor surgery and at every follow-up visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Throughout the study, an average of 2 years
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.
Throughout the study, an average of 2 years
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
Throughout the study, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Catholique de Louvain

Collaborators

Cliniques universitaires Saint-Luc

Investigators

  • Principal Investigator: Mireille Alhouayek, PhD, Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LICP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Pain

Clinical Trials on Blood sample + questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe