Ondansetron (ODF) Versus Ondansetron Intravenously for the Prevention of Chemotherapy-induced Nausea and Vomiting Compare in Children

Efficacy of Ondansetron Oral Soluble Film Combined With Dexamethasone Versus Ondansetron Intravenously Combined With Dexamethasone in Prophylaxis of Chemotherapy-induced Nausea and Vomiting in Pediatric Patients : A Multi-center, Randomized, Parallel Controlled, Non-inferior Clinical Study.

The purpose is to evaluate the efficacy of ondansetron oral soluble film plus dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) with MEC/HEC chemotherapy in children with solid tumor.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Solid Tumor, Unspecified, Protocol Specific
• Intervention / Treatment: Drug: Ondansetron (Oral soluble film OR injections) ,Dexamethasone

Detailed Description

Complete randomization was used to assign subjects to the experimental group (ondansetron oral soluble film plus dexamethasone) and the control group (ondansetron intravenously plus dexamethasone) in a ratio of 1 to 1. And a specialized software was used to generate random numbers to make a random assignment table.

Experimental:

Participants received the first dose of ondansetron oral soluble film (age-based adjustment) 30 minutes before chemotherapy and equal doses were given 4 hours and 8 hours after the first dose for whom younger than 12 years old while the others should be given 8h hours after the first dose. Ondansetron oral soluble film was administered continuously for two days after chemotherapy according to the administration regimen on the day of chemotherapy. Dexamethasone (weight based) iv/po twice daily and discontinued until 72 hours after chemotherapy.

Placebo Comparator:

Participants received the first dose of ondansetron intravenously (weight-based adjustment) 30 minutes before chemotherapy and equal doses were given 4 hours and 8 hours after the first dose. Ondansetron (po) was given for next continuously two days in the same dose and frequency of administration. Dexamethasone (weight based) iv/po twice daily and discontinued until 72 hours after chemotherapy.

• Study Type: Interventional
• Enrollment (Estimated): 376
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yizhuo Zhang; Phone Number: +86 87342460; Email: zhangyzh@sysucc.org.cn
• Study Contact Backup: Name: Yizhuo Zhang; Phone Number: +8687342460; Email: zhangyzh@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Yi-Zhuo Zhang, MD; Phone Number: 87342460; Email: zhangyzh@sysucc.org.cn

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Children aged 6 months to 18 years at the time of randomization;
2. Diagnosed of solid tumor by cytological or histological examination;
3. Going to initiate MEC/HEC chemotherapy;
4. PS score ≤ 2 points;
5. predicted life expectancy ≥3 months and weight greater than 6Kg;
6. Patient's parent or guardian signs informed consent

Exclusion Criteria:

1. Has vomited in the 24 hours prior to chemotherapy initiation on Treatment Day 1 ;
2. Has a symptomatic primary or metastatic central nervous system (CNS) malignancy with nausea and/or vomiting (asymptomatic participants may participate in study) ;
3. Will be receiving stem cell rescue therapy within 14 days following administration of ondansetron ;
4. Has experienced High emetic chemotherapy within two weeks ;
5. Has received or will receive total body irradiation to the abdomen or pelvis in the week prior to Treatment Day 1 and/or during the diary reporting period (120 hours following initiation of chemotherapy) ;
6. Has had benzodiazepine, opioid or opioid like therapy initiated within 48 hours prior to study drug administration, or is expected to receive within 120 hours following initiation of chemotherapy except for single doses of midazolam, temazepam or triazolam ;
7. Has started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is expected to receive a corticosteroid as part of the chemotherapy regimen ;
8. Allergic to Ondansetron and dexamethasone ;
9. Has an active infection (e.g., pneumonia), congestive heart failure, bradyarrhythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy ;
10. Is mentally incapacitated or has a significant emotional or psychiatric disorder ;
11. Has a known history of QT prolongation or is taking any medication that is known to lead to QT prolongation ;
12. Abnormal liver function (alanine aminotransferase or aspartate aminotransferase ≥ 2 times higher than the upper bound of the normal value) or abnormal renal function (serum creatinine ≥ 2.5 times higher than the upper bound of the normal value) ;
13. Is currently taking, or has taken within 48 hours of Treatment Day 1 the following drugs with antiemetic properties: 5-hydroxytryptamine 3 (5-HT3) antagonists (e.g., ondansetron), benzamides (e.g., haloperidol), cyclizine, domperidone, herbal therapies with potential antiemetic properties, olanzapine, phenothiazines (e.g., prochlorperazine), scopolamine (this is not an exhaustive list) ;
14. Has ever participated in a previous study of ondansetron or has taken an investigational drug with the last 4 weeks ;
15. other situations in which the researchers believe that they cannot be included in the group.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oral soluble film of ondansetron combined with dexamethasone; Participants received the first dose of ondansetron oral soluble film (age-based adjustment) 30 minutes before chemotherapy and equal doses were given 4 hours and 8 hours after the first dose for whom younger than 12 years old while the others should be given 8h hours after the first dose. Ondansetron oral soluble film was administered continuously for two days after chemotherapy according to the administration regimen on the day of chemotherapy. Dexamethasone (based on body surface area) iv/po twice daily from day 1 of chemotherapy until 2 days after completion of chemotherapy.	Drug: Ondansetron (Oral soluble film OR injections) ,Dexamethasone; Participants will randomly assigned 1:1 to receive treatment (Oral soluble film of Ondansetron plus dexamethasone OR Ondansetron injections plus dexamethasone).; Other Names: Ondansetron，Dexamethasone
Active Comparator: ondansetron intravenously combined with dexamethasone; Participants received the first dose of ondansetron intravenously (weight-based adjustment) 30 minutes before chemotherapy and equal doses were given 4 hours and 8 hours after the first dose. Ondansetron (po) was given for next continuously two days in the same dose and frequency of administration. Dexamethasone (based on body surface area) iv/po twice daily from day 1 of chemotherapy until 2 days after completion of chemotherapy.	Drug: Ondansetron (Oral soluble film OR injections) ,Dexamethasone; Participants will randomly assigned 1:1 to receive treatment (Oral soluble film of Ondansetron plus dexamethasone OR Ondansetron injections plus dexamethasone).; Other Names: Ondansetron，Dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response Rate (CR rate)	The proportion of patients with complete response (CRR, defined as no vomiting and no rescue therapy administered) within the acute phase (0-24h) after starting chemotherapy.	between 0 and 24 hours after the start of chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CR rate in delayed phase	Complete response rate in delayed phase	>24～120 Hours Post Initiation of Chemotherapy
CR rate in overall phase	Complete response rate in overall phase	0~120 Hours Post Initiation of Chemotherapy
Complete control rate in the acute, delayed, overall phases	Complete control rate defined as no vomiting, no rescue therapy, and no slight nausea < grade 1	between 0 and 120 hours after the start of chemotherapy

Collaborators and Investigators

• Sponsor: Yizhuo Zhang
• Investigators: Principal Investigator: Yizhuo Zhang, SunYat Sen University Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: January 7, 2024
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Estimated): January 17, 2024

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dermatologic Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Antipruritics; Dexamethasone; Dexamethasone acetate; BB 1101; Ondansetron
• Other Study ID Numbers: SunYat-senU-ondansetron

Drug and device information, study documents

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