Viewing Study NCT06150898



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Last Modification Date: 2024-10-26 @ 3:14 PM
Study NCT ID: NCT06150898
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-11-29
First Post: 2022-03-30

Brief Title: Ketorolac and Pregabalin Effects on breaSt Cancer KePreSt
Sponsor: Jules Bordet Institute
Organization: Jules Bordet Institute

Study Overview

Official Title: 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: NOT_YET_RECRUITING
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: KePreSt
Brief 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 andor 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 patients adiposity as well as other confounding variable will be taken into account

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None