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

Efficacy of High Dose Dexamethasone in Prevention of Hypersensitivity Reaction Induced by Oxaliplatin: A Randomized Double-Blind Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240319009
Enrollment
194
Registered
2024-03-19
Start date
2025-05-18
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

colon cancer oxaliplatin hypersensitivity reaction colon cancer oxaliplatin hypersensitivity reaction high dose dexamethasone

Interventions

1. Chemotherapy Nurse Initiates IV Access and Starts Hydration Starts a peripheral IV line with 1,000 mL of D5W at a rate of 40 mL per hour. 2. Chemotherapy Nurse Administers Premedication Administer
Active Comparator Drug,Active Comparator Drug
dexamethasone 20 mg,dexamethasone 12 mg

Sponsors

Sisaket Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactChatsuda Sookthon

Si Sa Ket Hospital

chatsuda.sook@gmail.com0802576576

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026