Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt) (NCT06150898) | Clinical Trial Compass
RecruitingPhase 2
Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)
Belgium112 participantsStarted 2025-05-12
Plain-language summary
Out of all proportion to its short duration, the perioperative period is critical in determining the long-term outcome of cancer.
To contribute to a better understanding of the neural and inflammatory mechanisms underlying this issue, we aim to implement a novel intervention based on the preoperative use of non-steroidal anti-inflammatory drugs (NSAIDs) with or without an anti-epileptic drug.
Our goal is to understand and transform the perioperative window from being a facilitator of metastatic progression to arresting and/or eliminating residual disease using repurposing drugs
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. Age ≥ 18 years and ≤ 70 years old
✓. Female
✓. Weight ≥ 35 kg
✓. Histological diagnosis of invasive breast adenocarcinoma that is estrogen receptor positive as per the updated American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) guidelines according to local testing with ER-positive is defined as having an immunohistochemistry (IHC) of 1% or more and/or Allred score of 3 or more
✓. Tumour size ≥ 1.5 cm, determined by diagnostic ultrasound or MRI/CT scan.
✓. Stage I, II or III disease (non-metastatic)
✓. In case of multifocal, multicentric unilateral or bilateral breast: Adenocarcinoma tumours are allowed provided that all foci are ER+ according to local testing
✓. Subject scheduled for a primary breast cancer surgery
Exclusion criteria
✕. Subject planned for intraoperative radiotherapy
What they're measuring
1
To detect a reduced increase in systemic inflammation (from baseline to up to 24 hours after surgery) using peri-operative ketorolac
Timeframe: Up to 24 hours after surgery
2
To detect a reduced increase in systemic neurotransmitters (from baseline to up to 24 hours after surgery) using peri-operative pregabalin
Timeframe: Up to 24 hours after surgery
3
Change in biomarkers of metastasis at surgery from baseline
Timeframe: At surgery
4
Change in tumoral immune cells recruitment at surgery from baseline
Timeframe: At surgery
5
Change in tumoral neurogenesis at surgery from baseline
Timeframe: At surgery
6
Change in tumoral neurotransmitters level at surgery from baseline
Timeframe: At surgery
7
Change in Peripheral Blood Mononuclear Cells at surgery from baseline
Timeframe: At surgery
8
Change in systemic neuro-inflammatory mediators at surgery from baseline
✕. Known hypersensitivity reactions to the investigational treatments, or any excipients or auxiliary medicinal products or concomitant medications. Hypersensitive to peanut or soya (related to propofol contraindications)
✕. Current use of the antidiabetic agent thiazolidinedione (related to interaction with pregabalin), lithium salts, probenecid, pentoxifylline or intensive diuretic therapy.
✕. Current NSAID (\> twice a week the year prior to diagnosis) or pregabalin use
✕. Previous malignant pathology within 5 years prior to inclusion or currently undergoing maintenance therapy. Exceptions include basal cell carcinoma or squamous cell carcinoma of the skin that have undergone potentially curative therapy or in situ cervical cancer.
Timeframe: At surgery
9
Change in systemic neurotransmitters at surgery from baseline