NCT06080880

Ondanstron Weekly vs Every 3 Weeks for Prevention of Nausea and Vomiting Induced by Chemotherapy Combined With PD-1 Blockade

Ondanstron Weekly vs Every 3 Weeks for Prevention of Nausea and Vomiting Induced by Chemotherapy Combined With PD-1 Blockade：an Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Hubei Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this randomized study is to compare the efficacy and safety of ondanstron weekly with every 3 weeks for the prevention of nausea and vomiting induced by chemotherapy combined with PD-1 blockade.

Detailed description

Nausea and vomiting have become the most common and intolerant adverse events in patients receiving chemotherapy, which cause substantial impairments in human functions and quality of life. In some serious cases, patients refused further treatment and lead to disruption of the course of treatment. For highly emetogenic chemotherapy(HEC), a standard triple therapy including 5-hydroxytryptamine-3 receptor antagonist(5-HT3RA), neurokinin-1 receptor antagonist(NK-1RA) plus corticosteriod. Recently, a few trials have achieved success in reduction of post-discharge application of corticosteriod based on the standard triple therapy, which offered new insights to update the current therapeutic regimens. Although the emetogenicity of PD-1 blockade seems to be slighter than HEC, previous studies have reported gastrointestinal immune-related adverse events(GI-IrAE) in patients treated with PD-1 blockade, of which 55% of the participants suffered nausea and vomiting. Noteworthy, recently researchers highlight the importance of prevention and control of nausea more than that of vomiting in terms with chemotherapy-induced nausea and vomiting. Therefore, the investigators initiated this study to compare the efficacy and safety of ondanstron weekly with every 3 weeks for the prevention of nausea and vomiting induced by chemotherapy combined with PD-1 blockade, which may provide new insights for fully prevention and control compare the efficacy and safety of ondanstron weekly with every 3 weeks for the prevention of nausea and vomiting induced by chemotherapy combined with PD-1 blockade in aimed population.

Conditions

• Nausea With Vomiting Chemotherapy-Induced

Interventions

Type	Name	Description
DRUG	Ondansetron every 3 weeks	Ondansetron, Po, 24mg/d, 3 days' application every 3 weeks
DRUG	Aprepitant	aprepitant, Po, 125mg/d, 1day' application every 3 weeks
DRUG	Dexamethasone	dexamethasone, iv, 10mg/d, 1day' application every 3 weeks
DRUG	Ondansetron weekly	Ondansetron, Po, 24mg/d, 3 days' application weekly

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-11-01
• Completion: 2027-11-01
• First posted: 2023-10-12
• Last updated: 2024-02-29

Locations

1 site across 1 country: China