Ondansetron Orodispersible Film for Vomiting Prevention in Pediatric Radiotherapy

NCT07217600 | Recruiting Phase 4

• 2 other identifiers: CZLS2024304-AChiCTR2400093665
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the antiemetic efficacy and drug safety of ondansetron orodispersible film in pediatric patients with malignant tumors who received moderate emetic risk radiation induced vomiting, and to formulate reasonable and effective clinical medication regimen for preventing vomiting caused by moderate emetic risk radiation in children with malignant tumor.

Conditions

Radiotherapy-induced Nausea and Vomiting (RINV); Pediatric Cancer

Outcome Measures

Primary Outcomes (1)

• Efficacy in preventing vomiting between the two groups, as per the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0

  Vomiting was divided into 5 grades according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0

  From the first day of radiotherapy to 7 days after the end of radiotherapy

Secondary Outcomes (2)

• Adverse reaction rate

  From the first day of radiotherapy to 7 days after the end of radiotherapy

• The frequency of rescue treatments

  From the first day of radiotherapy to 7 days after the end of radiotherapy

Study Arms (2)

group QD

EXPERIMENTAL

Drug: Ondansetron orodispersible film once

group BID

ACTIVE COMPARATOR

Drug: Ondansetron orodispersible film twice

Interventions

Ondansetron orodispersible film once DRUG

Take ondansetron orodispersible film once 1-2 hours before each radiotherapy

group QD

Ondansetron orodispersible film twice DRUG

Take ondansetron orodispersible film once before each radiotherapy , and once again 8 hours after the first dose.

group BID

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with malignant tumors diagnosed by histopathology
• Age range: 1-14 years old (calculated from the day of signing the informed consent form)
• Weight \>= 8Kg;
• Lansky functional status (LPS) score \>= 50 (excluding posterior fossa syndrome)
• Be planned to undergo upper abdominal or craniospinal radiation therapy, and the upper abdominal irradiation should cover the anatomical area from the upper edge of the 11th thoracic vertebra to the lower edge of the third lumbar vertebra
• Radiotherapy is administered once daily, and the fractional dose is 1.8Gy, except for 1.5 Gy for whole abdominal radiotherapy
• The blood routine test must meet the following criteria: ANC \>= 1.0 × 10\^9/L (after discontinuation of G-CSF), PLT \>= 50 × 10\^9/L (without drug support or transfusion therapy), HGB \>= 80g/L
• Biochemical tests must meet the following standards: total bilirubin \<= 1.5 times ULN (upper limit of normal), ALT \<= 2.5 times ULN, AST \<= 2.5 times ULN, alkaline phosphatase ≤ 1.5 times ULN, serum albumin \>= 2.5 g/dL, BUN and CRE \<= 1.5 × ULN
• Expected survival period \>= 3 months;
• The guardian of the child understands and signs the informed consent form, has good compliance, and cooperates with follow-up.

You may not qualify if:

• The nausea and vomiting caused by the surgery have not fully recovered if the subject has undergone a major surgery
• The patient has symptoms of central nervous system tumors such as cerebral edema and requires intervention with adrenal cortex hormones
• Participants who have participated in or are currently participating in other clinical studies within 4 weeks prior to the first use of the investigational drug (calculated based on the time of the last use of the investigational drug for those who have entered the follow-up period)
• Individuals allergic to 5-HT3 receptor antagonists or other excipients
• Joint use of apomorphine
• Congenital QT prolongation syndrome
• Severe gastrointestinal obstruction
• Other observers who affect the efficacy and adverse reactions
• Used other 5-HT3 receptor antagonists in the first 3 days of enrollment
• According to the researchers' assessment, there may be other factors that could force the subjects to terminate the study midway, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the safety of the subjects or the collection of experimental data.

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead

Study Sites (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

MeSH Terms

Conditions

Vomiting; Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yue Xie

  Chongqing University Cancer Hospital, Chongqing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Xie

CONTACT

+86 13883080833; 344899525@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: October 16, 2025
• Study Start: March 25, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)