Comparing oral and intravenous ondansetron for preventing nausea in children undergoing chemotherapy

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.

This study is testing whether a new way of giving ondansetron as a dissolvable film works better than the traditional intravenous method to prevent nausea in children receiving chemotherapy.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 376 (estimated)
• Ages: 6 Months to 18 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06208917 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of ondansetron oral soluble film combined with dexamethasone versus ondansetron administered intravenously with dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) in children diagnosed with solid tumors. Participants aged 6 months to 18 years will be randomly assigned to either treatment group, receiving their respective medications before and after chemotherapy. The study aims to determine which method is more effective in managing CINV during moderate to highly emetogenic chemotherapy regimens.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 6 months to 18 years who are about to start moderate to highly emetogenic chemotherapy for solid tumors.

Not a fit: Patients who have experienced vomiting in the 24 hours prior to chemotherapy or have symptomatic CNS malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective method for preventing nausea and vomiting in pediatric cancer patients undergoing chemotherapy.

How similar studies have performed: Previous studies have shown that ondansetron is effective in preventing CINV, but this specific comparison of oral versus intravenous administration in children is novel.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Yizhuo Zhang — SunYat Sen University Cancer Center
• Study coordinator: Yizhuo Zhang

Conditions: Pediatric Solid Tumor, Unspecified, Protocol Specific