Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Nutritional and Metabolic Diseases

Inflammation

Breast Neoplasms

Obesity

Breast Diseases

Skin Diseases

Channel Blockers

Analgesics

Anticonvulsants

Central Nervous System Depressants

Psychotropic Drugs

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Bone Density Conservation Agents

Pregabalin

Ketorolac

Ketorolac Tromethamine

Calcium

Calcium Channel Blockers

Calcium, Dietary

Hormones

Anti-Anxiety Agents

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Control group: Standard of care

Number of subjects: 28 (14 lean patients, defined as Body mass index \<25 kg/m², and 14 overweight/obese patients, defined as BMI ≥25 kg/m² )

Investigational Medicinal Product (IMP): Ketorolac

Number of subjects: 28 (14 lean patients, defined as Body mass index \<25 kg/m², and 14 overweight/obese patients, defined as BMI ≥25 kg/m² )

Investigational Medicinal Product (IMP): Pregabalin

Number of subjects: 28 (14 lean patients, defined as Body mass index \<25 kg/m², and 14 overweight/obese patients, defined as BMI ≥25 kg/m² )

Investigational Medicinal Products (IMPs): Ketorolac and pregabalin

Number of subjects: 28 (14 lean patients, defined as Body mass index \<25 kg/m², and 14 overweight/obese patients, defined as BMI ≥25 kg/m² )

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

Prospective data and sample collection

Patients will receive 10 mg film-coated tablets of ketorolac tromethamine three times a day, for five days before the surgery

Ketorolac 10 Mg Oral Tablet

Patients will receive 75 mg of pregabalin hard capsule twice a day, for seven days before the surgery

Pregabalin 75mg

Imane Bachir, MD

Marion Maetens, PhD

Maher Khalife, MD

Laurence Buisseret, MD, Phd

Isabelle Veys, MD

Elia Biganzoli, PhD

Juan A Rodriguez Arango, MD

Denis Larsimont, MD, PhD

Christine Desmedt, PhD

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

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.

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

Calculated: body mass (kg) divided by height squared (m²)

Calculated from multiple frequency bio-impedance measurements (in %, range \[0 - 100\])

Waist circumference (cm) divided by hip circumference (cm)

Plasma multiplex technology using cytometric bead arrays

Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)

Transcriptome profile and bioinformatic analysis

Characterization of Tumour-infiltrating leukocyte subpopulations using RNA sequencing analysis from fresh frozen tissue sections

Level of neurogenesis markers using RNA sequencing analysis from fresh frozen tissue section

Using RNA sequencing analysis from fresh frozen tissue sections

Fluorescence activated cell sorting (FACS) analysis

Generalized Anxiety Disorder - 7 (GAD - 7) Anxiety score (natural number, range\[0 - 21\]. A score comprised between 0 - 4 indicates a minimal anxiety, 5-9 a mild anxiety, 10-14 a moderate anxiety and a 15-21 in a severe anxiety.

Consumption of morphine delivered by a programmable patient-controlled analgesia (PCA) infusion pump (number of requested and effectively delivered bolus/ 24h)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)	NCT06150898	Early-stage Bre... Estrogen-recept...	Prospective dat... Ketorolac 10 Mg... Pregabalin 75mg	18 Years - 70 Years	Jules Bordet Institute
Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)	NCT06150898	Early-stage Bre... Estrogen-recept...	Prospective dat... Ketorolac 10 Mg... Pregabalin 75mg	18 Years - 70 Years	Jules Bordet Institute

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