Health TrialsbyHealthPanel

Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)

ConditionsEarly-stage Breast CancerEstrogen-receptor-positive Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorJules Bordet Institute

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Subject planned for intraoperative radiotherapy

Subject planned for immediate reconstruction

Neoadjuvant BC therapy

Allergy to any NSAID or gabapentinoïd

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prospective data and sample collection

    Procedure/Surgery

    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

  • Ketorolac 10 Mg Oral Tablet

    Drug

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

  • Pregabalin 75mg

    Drug

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

  • Omeprazole 20mg Capsule

    Drug

    Patients will receive 20 mg of omeprazole once a day on an empty stomach, for five days before the surgery

Treatment groups

112 Participants
are divided into 4 treatment groups
Group A: No pre-operative treatmentExperimental treatment 2 interventions
Group B: Pre-operative ketorolacExperimental treatment 3 interventions
Group C: Pre-operative pregabalinExperimental treatment 3 interventions
Group D: Pre-operative ketorolac and pregabalinExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

To detect a reduced increase in systemic inflammation (from baseline to up to 24 hours after surgery) using peri-operative ketorolac

Plasma multiplex technology using cytometric bead arrays

Time frame
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

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

Time frame
Up to 24 hours after surgery
3

Change in biomarkers of metastasis at surgery from baseline

Transcriptome profile and bioinformatic analysis

Time frame
At surgery
4

Change in tumoral immune cells recruitment at surgery from baseline

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

Time frame
At surgery

Secondary outcomes

1

Change in anxiety level at surgery from baseline

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.

Time frame
At surgery
2

Post-operative pain

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

Time frame
Up to 48 hours after surgery

Other outcomes

1

Body Mass Index

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

Time frame
The day before surgery
2

Body composition

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

Time frame
The day before surgery
3

Waist-to-hip ratio

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

Time frame
The day before surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jules Bordet Institute

Lead sponsor

KU Leuven

Collaborator

Source ClinicalTrials.gov
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