Breast Cancer Female, Postoperative Pain
Conditions
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.
Interventions
OTHERBlood sample + questionnaire
* blood sample before tumor surgery and at every follow-up visit * questionnaire before tumor surgery and at every follow-up visit
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Université Catholique de Louvain
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium
Contacts
Primary ContactMartine Berlière, MD, PhD
Backup ContactLisa Martin, MSC
Outcome results
None listed