Efficacy of High Dose Dexamethasone in Prevention of Hypersensitivity Reaction Induced by Oxaliplati

Phase 2

Recruiting

• Conditions: colon canceroxaliplatin hypersensitivity reaction; colon cancer; oxaliplatin hypersensitivity reaction; high dose dexamethasone

• Registration Number: TCTR20240319009
• Lead Sponsor: Sisaket Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-19
• Last Update Posted: 19 August 2024
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 194

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
events of oxaliplatin hypersensitivity reaction occurs for each arm after all subjects compelete chemotherapy protocol the presence or absence of allergic reactions to oxaliplatin

Secondary Outcome Measures

Name	Time	Method
exacerbation of diabetes after all subjects compelete chemotherapy protocol fasting plasma glucose,osteoporosis after all subjects compelete chemotherapy protocol bone mineral density (BMD),Compression fracture after all subjects complete chemotherapy protocol film X-ray spine,Edema after all subjects complete chemotherapy protocol pitting edema grading scale