Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)
NCT06150898 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112
Last updated 2025-06-13
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
Conditions
- Early-stage Breast Cancer
- Estrogen-receptor-positive Breast Cancer
Interventions
- PROCEDURE
-
Prospective data and sample collection
Core-needle biopsy of the breast (pre-treatment), surgical sample collection (post-treatment), extra collection of blood samples (pre- and post-treatment), measurements of adiposity, lifestyle questionaire
- DRUG
-
Ketorolac 10 Mg Oral Tablet
Patients will receive 10 mg film-coated tablets of ketorolac tromethamine three times a day, for five days before the surgery
- DRUG
-
Pregabalin 75mg
Patients will receive 75 mg of pregabalin hard capsule twice a day, for seven days before the surgery
- DRUG
-
Omeprazole 20mg Capsule
Patients will receive 20 mg of omeprazole once a day on an empty stomach, for five days before the surgery
Sponsors & Collaborators
-
KU Leuven
collaborator OTHER -
Jules Bordet Institute
lead OTHER
Principal Investigators
-
Christine Desmedt, PhD · KU Leuven
-
Imane Bachir, MD · Jules Bordet Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-12
- Primary Completion
- 2027-04-20
- Completion
- 2027-10-31
Countries
- Belgium
Study Locations
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