Skip to content

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)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000041550
Enrollment
32
Registered
2015-01-20
Start date
2015-02-03
Completion date
2015-08-11
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 e

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.

Sponsors

Peter MacCallum Cancer Centre
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- 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 criteria

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 11, 2026