Clinical trial · Interventional
Effect of Celecoxib on Perioperative Inflammatory Response in Colon Cancer
The Effect Of Celecoxib On The Perioperative Inflammatory Response In Colon Cancer Patients - A Double-Blind Placebo-Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual rate; the only participant withdrew after signing consent
Summary
Brief summary (as posted)
The proposed study aims to investigate how the administration of a drug known to reduce inflammation in humans, Celecoxib, will effect the peri-operative inflammatory response of a patient undergoing primary tumor resection surgery for colon cancer. The proposed project is an exploratory study, and will use data from blood samples and tumor samples to attempt to elucidate the immune and inflammatory response in colon cancer patients undergoing primary resection of their tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Celecoxib
- description
- Celecoxib, 200 mg tab
- interventionNames
- Drug: Celecoxib
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- placebo, tab
- interventionNames
- Other: placebo
Primary outcomes (2)
- measure
- Tumor Sample - Analyzed for TCR Repertoire and Global Transcription Profiling
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: \- Colon cancer patients with no evidence of metastasis in distant organs (i.e., TNM stage I-III), who are * between 18 and 75 years old, * have a body mass index (BMI) between 18 and 35 kg/m\^2, * and are eligible for laparoscopically-assisted colectomy for primary tumor resection. * Patients must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: \- A history of allergic-type reactions to celecoxib or sulphonamides, * a history of asthma, skin reactions or other allergic reactions to aspirin or other NSAIDs, * a history of thromboembolic event (cerebrovascular accident, transient ischemic attack, * unstable angina, myocardial infarction, deep vein thrombosis, or pulmonary embolism), * renal insufficiency (defined by a serum creatinine level \> 1.5 mg/dL or blood urea nitrogen level \> 22 mg/dL), * active gastrointestinal bleeding in the 60 days before surgery, * alcohol or drug abuse, and * previous chemotherapy or abdominal/pelvic radiation therapy. * After randomization, other exclusion criteria will include a surgical procedure longer than 6 h, inability to extubate the trachea within 4 h after operation, evidence of a new postoperative myocardial infarction, abnormal postoperative mental status or any new neurologic deficit, significant postoperative bleeding (with a hemoglobin level \< 7.5 g/dL), requiring blood transfusion, or a urine output of less than 30 mL/h.
References
Publications (0)
Data not yet available