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

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.

Study Overview

• Status: Recruiting
• Conditions: Nausea With Vomiting Chemotherapy-Induced
• Intervention / Treatment: Drug: Ondansetron every 3 weeks; Drug: Aprepitant; Drug: Dexamethasone; Drug: Ondansetron weekly

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.

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guang Han, MD; Phone Number: 13886048178; Email: hg7913@hotmail.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Recruiting
      • Hubei Cancer Hospital
      • Contact: Han Guang, MD
      • Principal Investigator: Han Guang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years, no gender limit;
2. Pathologically or cytologically confirmed malignant solid tumors;
3. Scheduled to receive cisplatin-based chemotherapy combined with PD-1 blockade；
4. TPS > 1 %(PD-1);
5. Adequate hematological function (leucocyte count ≥ 4000/μL [to convert to ×109/L,multiply by 0.001], hemoglobin ≥ 9.00 g/dL [to convert to grams per liter, multiply by 10], and platelet count ≥ 100 × 103/μL [to convert to ×109/L, multiply by 1]);
6. Hepatic function (alanine aminotransferase and aspartate aminotransferase ≤ 2.0 times the upper limit of the reference ranges), and renal function (creatinine clearance ≥ 60 mL/min/1.73 m2 [to convert to millimeters per second per meter-squared, multiply by 0.0167])；
7. Estimated survival time > 6 months；
8. ECOG 0-1 points；
9. Participants being informed and signed written consents.

Exclusion Criteria:

1. Nausea or vomiting caused by reasons except for chemotherapy and PD-1 blockade;
2. Participants with other malignant tumors history previously;
3. Inability to read, comprehend, and finish questionnaires;
4. Allergic to the drugs included in this study.
5. Administered drugs with antiemetic activity within the 24 hours before receiving the first dose of study medication.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ondansetron every 3 weeks combined with aprepitant and dexamethasone	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
Experimental: Ondansetron weekly combined with aprepitant and dexamethasone	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete response(CR) rate	Defined as no emesis and no rescue therapy	Up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients with sustained no emesis, sustained no nausea, sustained no significant nausea, and the mean time to first emetic episode.	The proportion of patients with sustained no emesis, sustained no nausea, sustained no significant nausea (defined as no or mild nausea), and the mean time to first emetic episode.	Assessed every week

Collaborators and Investigators

• Sponsor: Hubei Cancer Hospital
• Investigators: Principal Investigator: Guang Han, MD, Hubei Cancer Hospital, Wuhan, HuBei, China, 430079

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: October 8, 2023
• First Submitted That Met QC Criteria: October 8, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: PD-1 blockade; Chemotherapy-induced nausea and vomiting; Ondanstron
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dermatologic Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Antipruritics; Neurokinin-1 Receptor Antagonists; Dexamethasone; Ondansetron; Aprepitant
• Other Study ID Numbers: 2023-143-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No