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Efficacy of Olanzapine 5 mg versus 10 mg for the Prophylaxis of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving High Emetic Risk Chemotherapy,without Neurokinin-1 Receptor Antagonist

Efficacy of Olanzapine 5 mg versus 10 mg for the Prophylaxis of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving High Emetic Risk Chemotherapy,without Neurokinin-1 Receptor Antagonist

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200708006
Enrollment
140
Registered
2020-07-08
Start date
2020-06-17
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Chemotherapy&#45

Interventions

Day1: Dexa 20 mg IV+ Ondansetron 8 mg IV and 8 mg oral in the morning the day after chemotherapy +Olanzapine 10 mg oral dinner Day2&#45
4: Dexa 4 mg oral bid pc+ Olanzapine 10 mg/day dinner ,Day1: Dexa 20 mg IV+ Ondansetron 8 mg IV and 8 mg oral in the morning the day after chemotherapy +Olanzapine 5 mg oral dinner Day2&#45
4: Dexa 4 mg oral bid pc+ Olanzapine 5 mg/day dinner
Active Comparator Drug,Experimental Drug
O&#45
10,O&#45

Sponsors

None
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age ≥ 18 year-old 2. Receiving the first cycle of doxorubicin/cyclophosphamide or high-dose cisplatin (≥70mg/m2) 3. Eastern Cooperative Oncology Group performance status 0 to 2 4. Adequate organ function (absolute neutrophil count ≥2000 cell/uL, aminotransferase 50 ml/min)

Exclusion criteria

Exclusion criteria: 1. Symptomatic Brain Metastasis 2. Pregnancy or Breast-feeding 3. Allergy to agents in the study 4. Receiving anticonvulsants or fluoro-quinolone antibiotic 5. History of receiving NK-1 RA, 5-HT3 receptor antagonists, dexamethasone, dopamine receptor antagonists, antihistamines, benzodiazepine and antipsychotics in 48-hour, previously 6. Receiving abdominal radiotherapy 7. History of heart disease or arrhythmia or uncontrolled heart failure or acute myocardial infarction in 6 months previously or uncontrolled diabetes

Design outcomes

Primary

MeasureTime frame
Complete response (no emesis+no rescue treatment) at 5 days after receiving chemotherapy record form—

Secondary

MeasureTime frame
No nausea at 5 days after receiving chemotherapy VAS <5mm,Adverse events at 5 days after receiving chemotherapy CTCAE version 5.0—

Countries

Thailand

Contacts

Public ContactSitthi Sukauichai

Chemotherapy Unit

maxstmdcu@yahoo.com038 455 456

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026