NCT05244577

Olanzapine Combined With Fosaprepitant, Ondansetron, and Dexamethasone for Preventing Nausea and Vomiting in Patients With Testicular Cancer

A Phase III Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate Olanzapine Combined With Fosaprepitant, Ondansetron, and Dexamethasone for Preventing Nausea and Vomiting in Patients With Testicular Cancer Receiving 5-day Cisplatin Combination Chemotherapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Shi Yanxia · Academic / Other
• Sex: Male
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the efficacy and safety of olanzapine combined with fosaprepitant, ondansetron and dexamethasone compared with placebo combined with fosaprepitant, ondansetron and dexamethasone in the prevention of nausea and vomiting in germ-cell tumors receiving 5-day cisplatin chemotherapy

Detailed description

This is a prospective, randomized, double-blind, placebo-controlled, cross-over Phase III clinical study. A total of 75 patients were enrolled in two sequential treatment groups (olanzapine-placebo and placebo-Olanzapine). (1) The screening process begins after the patient signs the written informed consent. (2) Patients were randomly divided into control group (placebo) and experimental group (olanzapine). (3) Patients' effectiveness from the beginning of chemotherapy drug infusion (0 h on day 1) to day 10 (approximately 240 h) was monitored by patients' diary from 2 to 10 days after chemotherapy, in which patients should report episodes of vomiting in the previous 24 hours, use of remedial therapy, and assessment of daily nausea. Any episodes of vomiting or retching, as well as the time and date of use of rescue medications, should also be recorded. At days 2 to 6, patients were assessed on the visual analog scale (VAS) for the previous 24 hours. (4) The Hospital Anxiety and Depression Scale (HADS),and Life Index - Vomiting (FLIE) questionnaire of days 1-10 should be completed immediately after the log is completed on day 10. (5) During the study period, patients may receive "remedial treatment" for nausea or vomiting, and patients requiring remedial treatment are considered to have failed treatment because the primary endpoint is complete remission. However, patients receiving remedial treatment must continue to receive the study drug and complete the diary as directed.

Conditions

• Olanzapine
• CINV
• Testicular Cancer by AJCC V6 and V7 Stage
• Cisplatin

Interventions

Type	Name	Description
DRUG	Olanzapine Tablets	Olanzapine,Ondansetron,Dexamethasone,Fosaprepitant
DRUG	Placebo	Placebo,Ondansetron,Dexamethasone,Fosaprepitant

Timeline

• Start date: 2022-01-18
• Primary completion: 2023-12-31
• Completion: 2024-03-31
• First posted: 2022-02-17
• Last updated: 2023-02-06

Locations

1 site across 1 country: China