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

NCT06208917 | Recruiting Phase 3

• 1 other identifier: SunYat-senU-ondansetron
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Solid Tumor, Unspecified, Protocol Specific

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• CR rate in delayed phase

  >24～120 Hours Post Initiation of Chemotherapy

• CR rate in overall phase

  0~120 Hours Post Initiation of Chemotherapy

• Complete control rate in the acute, delayed, overall phases

  between 0 and 120 hours after the start of chemotherapy

Study Arms (2)

oral soluble film of ondansetron combined with dexamethasone

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 (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

ondansetron intravenously combined with dexamethasone

ACTIVE 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 (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

Interventions

Ondansetron (Oral soluble film OR injections) ,Dexamethasone DRUG

Participants will randomly assigned 1:1 to receive treatment (Oral soluble film of Ondansetron plus dexamethasone OR Ondansetron injections plus dexamethasone).

Also known as: Ondansetron，Dexamethasone

ondansetron intravenously combined with dexamethasone; oral soluble film of ondansetron combined with dexamethasone

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Has vomited in the 24 hours prior to chemotherapy initiation on Treatment Day 1 ;
• Has a symptomatic primary or metastatic central nervous system (CNS) malignancy with nausea and/or vomiting (asymptomatic participants may participate in study) ;
• Will be receiving stem cell rescue therapy within 14 days following administration of ondansetron ;
• Has experienced High emetic chemotherapy within two weeks ;
• 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) ;
• 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 ;
• 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 ;
• Allergic to Ondansetron and dexamethasone ;
• Has an active infection (e.g., pneumonia), congestive heart failure, bradyarrhythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy ;
• Is mentally incapacitated or has a significant emotional or psychiatric disorder ;
• Has a known history of QT prolongation or is taking any medication that is known to lead to QT prolongation ;
• 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) ;
• 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) ;
• Has ever participated in a previous study of ondansetron or has taken an investigational drug with the last 4 weeks ;
• other situations in which the researchers believe that they cannot be included in the group.

Sponsors & Collaborators

• Yizhuo Zhang: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

Ondansetron; Injections; Dexamethasone

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Drug Administration Routes; Drug Therapy; Therapeutics; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Yizhuo Zhang

  SunYat Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yizhuo Zhang

CONTACT

+86 87342460; zhangyzh@sysucc.org.cn

Yizhuo Zhang

CONTACT

+8687342460; zhangyzh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: January 17, 2024
• Study Start: July 9, 2023
• Primary Completion: July 1, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

CN (1)