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

Phase 3

Completed

• Conditions: Chemotherapy- Induced Nausea and Vomiting; High Emetogenic Chemotherapy; Olanzapine

• Registration Number: TCTR20200708006
• Lead Sponsor: one

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-08
• Study Completion: 2021-02-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

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 < 100 IU/L, total bilirubin<2.0 mg/dl and creatinine clearance >50 ml/min)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete response (no emesis+no rescue treatment) at 5 days after receiving chemotherapy record form

Secondary Outcome Measures

Name	Time	Method
o nausea at 5 days after receiving chemotherapy VAS <5mm,Adverse events at 5 days after receiving chemotherapy CTCAE version 5.0