Celecoxib affecting inflammation following thoracic and abdominal surgery (Phase II study)
Celecoxib's effect on inflammatory response in patients receiving thoracic and abdominal surgery (Phase II study)
Peter MacCallum Cancer Centre
30 participants
Feb 3, 2015
Interventional
Conditions
Summary
This is a 30 patient single-centre, open-labeled, randomised pilot study assessing the effectiveness of a cyclooxygenase (Cox)-II specific inhibitor, Celecoxib, in reducing perioperative inflammation associated with thoracic and major abdominal surgery as assessed by blood and urinary markers. Information regarding Celecoxib's capacity to reduce perioperative pain and morphine consumption will also be sought. Patients will receive standard dosing of Celecoxib in accordance with on-license use. Demonstration of effect and feasibility of inflammation suppression is intended to lead to a multi-centre study investigating the use of perioperative Celecoxib to delay cancer recurrence following Non-Small Cell Lung Cancer (NSCLC) resection surgery.
Eligibility
Inclusion Criteria5
- Patients receiving thoracic surgery or laparotomy (expected duration greater than two hours) at Peter MacCallum Cancer Centre. Surgical subtypes include patients receiving thoracotomy or thoracoscopic surgery where surgery is performed in the intra-pleural space, and patients receiving a laparotomy (expected >2 hours);
- Age >18 years old;
- World Health Organization ECOG performance status 0 or 1;
- At least five days since use of prior non-steroidal anti-inflammatory agents including Aspirin, Celecoxib, Ibuprofen, Naproxen, Meloxicam, Diclofenac;
- Written, informed consent.
Exclusion Criteria7
- contraindications to celecoxib,
- robotic assisted thoracoscopic surgery,
- acute inflammatory condition (sepsis, infection),
- pregnancy or lactation,
- concurrent use of oral corticosteroid treatment or NSAID/aspirin (within a week prior to study entry),
- presence of neuroendocrine tumour,
- hepatic impairment (aspartate transaminase >240 u/L, alanine transaminase >110 u/L) renal impairment (creatinine >150 umol/L).
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Interventions
Patients are randomised to receive oral Celecoxib through the perioperative period, or no anti-inflammatory prescription. Specifically, patients in the Celecoxib group receive a loading dose of 400mg of oral Celecoxib capsules within 30 minutes prior to the induction of anaesthesia for surgery. Subsequently they receive 200mg of oral Celecoxib capsules at 12hourly intervals for a total of six dosing episodes (3 days). A ‘half-dose’ regimen will be adopted (200mg loading dose followed by 100mg every 12 hours for a total of six dosing events) in the following scenarios at registration: * Multiple cardiovascular risk factors: (any two of the following) 1. History of atherosclerotic disease; 2. Hypertension (treated with Angiotensin Converting Enzyme inhibitors, Angiotensin II receptor antagonists); 3. Cardiac failure (NYHA I). * Age older than 65 years as well as body weight less than 50kg. * Pre-operative Serum Creatinine of 100–149umol/L. Monitoring: Patients are seen daily on the wards by both treating clinicians and the study researchers following their surgery. Specifically, adverse events are enquired about, pain scores documented and standard post-operative blood tests acquired to monitor renal function. Pill compliance is documented. Patients are deemed compliant if they take at least 5/6 requested drug episodes. Additional to the standard post-operative bloods are post-operative blood tests that are taken at baseline (induction), and then 6hrs, 24hrs and 48hrs hours following surgery. These tests are for research purposes to measure the effectiveness of Celecoxib in limiting the prostaglandin rise (inflammatory response to surgery). A baseline urine sample and 48 hour urine same is also collected.
Locations(1)
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ACTRN12615000041550