NCT06150898

Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)

Unravelling the Local and Systemic Effects of Primary Surgery and Perioperative Use of Ketorolac and Pregabalin in Primary Breast Cancer Patients According to Adiposity

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

The perioperative period presents a unique window of therapeutic opportunities to counteract minimal residual growth and dormancy escape of cancer cells. The main physiological disturbances induced by the surgery, that enhance the tumoral growth in the perioperative period, are due to the neuronal and inflammatory signaling. We propose a therapeutic modelling of the inflammatory and neurological pathways in a phase II trial using ketorolac and pregabalin, alone or in combination. Ketorolac, a non-selective NSAIDs will target cyclooxygenase (COX)-enzymes, while pregabalin, an anti-epileptic drug will regulates the release of neurotransmitters. Moreover, both drugs have an effect on the postoperative pain and pregabalin has anxiolytic property. Thanks to this study, and through specific blockade, we want to understand how nervous and inflammatory systems remodel the tumour and systemic characteristics. To ensure an integrative analysis of those factors, patient's adiposity as well as other confounding variable will be taken into account.

Conditions

• Early-stage Breast Cancer
• Estrogen-receptor-positive Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-05-12
• Primary completion: 2027-04-20
• Completion: 2027-10-01
• First posted: 2023-11-29
• Last updated: 2025-06-13

Locations

1 site across 1 country: Belgium