Ondansetron Orodispersible Film for Vomiting Prevention in Pediatric Radiotherapy

NCT ID: NCT07217600

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-25
• Study Completion Date: 2026-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

group QD

Group Type: EXPERIMENTAL

Ondansetron orodispersible film once

Intervention Type: DRUG

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

group BID

Group Type: ACTIVE_COMPARATOR

Ondansetron orodispersible film twice

Intervention Type: DRUG

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

Interventions

Ondansetron orodispersible film once

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

Intervention Type: DRUG

Ondansetron orodispersible film twice

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chongqing University Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yue Xie

Deputy Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yue Xie

Role: PRINCIPAL_INVESTIGATOR

Chongqing University Cancer Hospital, Chongqing, China

Locations

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yue Xie

Role: CONTACT

344899525@qq.com

+86 13883080833

Facility Contacts

Yue Xie

Role: primary

344899525@qq.com

+86 138 8308 0833

Study Documents

Document Type: Study Protocol

View Document

Other Identifiers

ChiCTR2400093665

Identifier Type: REGISTRY

Identifier Source: secondary_id

CZLS2024304-A

Identifier Type: -

Identifier Source: org_study_id