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Clinical Trials/TCTR20240319009
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.

Registry
who.int
Start Date
March 19, 2024
End Date
January 31, 2025
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Sisaket Hospital

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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