Study of Lipid Mediators in Chronic Postoperative Pain Following Breast Cancer Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Pain intensity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Chronic pain
Intervention: Blood sample + questionnaire (Other)
No chronic pain
Intervention: Blood sample + questionnaire (Other)
Outcomes
Primary Outcomes
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.
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.
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
Secondary Outcomes
No secondary outcomes reported