Olanzapine Combined With Fosaprepitant, Ondansetron, and Dexamethasone for Preventing Nausea and Vomiting in Patients With Testicular Cancer
- Conditions
- OlanzapineCINVTesticular Cancer by AJCC V6 and V7 StageCisplatin
- Interventions
- Drug: Placebo
- Registration Number
- NCT05244577
- Lead Sponsor
- Shi Yanxia
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 75
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olanzapine Olanzapine Tablets Ondansetron 8mg IV, D1-5 30 minutes before chemotherapy; Dexamethasone 6mg Po QD, D1-7; Fosaprepitant 150mg IVD D1,4, 60 minutes before chemotherapy; Olanzapine 5mg Po D1-7 Placebo Placebo Ondansetron 8mg IV, D1-5 30 minutes before chemotherapy; Dexamethasone 6mg Po QD, D1-7; Fosaprepitant 150mg IVD D1,4, 60 minutes before chemotherapy; Placebo 5mg Po D1-7
- Primary Outcome Measures
Name Time Method Percentage of Participants With Complete Response From 0 to 240 Hours After Initiation chemotherapy 1 to 10 days Complete Response was defined as no vomiting and no use of rescue medication
- Secondary Outcome Measures
Name Time Method Percentage of Participants with total control 1 to 10 days total control was defined as no vomiting, no rescue antiemetics, and no nausea
Percentage of Participants With minimal nausea 1-10 days Minimal nausea was defined as \<25 mm on a visual analog scale
Severity of nausea 1 to 10 days Number of rescue medications 1 to 10 days Number of rescue medications for nause and vormitting
Time to Treatment Failure in each group of participates 1 to 10 days Time to treatment failure was defined as time to 1st emetic episode or use of rescue medication
Patient's satisfaction with anti-emetic therapy 1 to 10 days The patient was asked to evaluate his satisfaction with the control of nausea and vomiting by recording two scales: Hospital Anxiety and Depression Scale and The Functional Living Index-Emesis questionnaire
Trial Locations
- Locations (1)
Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China