TCTR20240319009
Recruiting
Phase 2
Efficacy of High Dose Dexamethasone in Prevention of Hypersensitivity Reaction Induced by Oxaliplatin: A Randomized Double-Blind Controlled Trial
Sisaket Hospital0 sites194 target enrollmentMarch 19, 2024
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- colon canceroxaliplatin hypersensitivity reaction
- Sponsor
- Sisaket Hospital
- Enrollment
- 194
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with cancer, aged at least 18 years, diagnosed with colorectal cancer who have received oxaliplatin
- •2\. In the case of metastatic disease, participants must not have received oxaliplatin before
- •3\. In the case of adjuvant oxaliplatin treatment, it must be stopped at least 6 months before entering the study
- •4\. ECOG performance status 0\-2
- •4\. Life expectancymmore than 12 weeks
- •5\. Blood test results: ANC more than 1,000/mm3, platelet more than 75,000, Hb more than 8 g/dL, total bilirubin more than 2, Cr less than 1\.5 times the upper normal limit
- •6\. Patients who have signed informed consent to participate in the research project
Exclusion Criteria
- •1\. Patients with a history of severe allergic reactions to oxaliplatin or other platinum\-containing compounds
- •2\. Patients with severe hypersensitivity to other drugs or excipients in the study drug
- •3\. Patients with uncontrolled underlying diseases
- •4\. Patients with multiple primary cancers in the past 5 years
- •5\. Patients with pleural effusion, pericardial effusion, or ascites that require drainage
- •6\. Patients with significant mental or psychological illness
Outcomes
Primary Outcomes
Not specified
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