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Trial Title:
Ondansetron (ODF) Versus Ondansetron Intravenously for the Prevention of Chemotherapy-induced Nausea and Vomiting Compare in Children
NCT ID:
NCT06208917
Condition:
Pediatric Solid Tumor, Unspecified, Protocol Specific
Conditions: Official terms:
Vomiting
Dexamethasone
Dexamethasone acetate
Ondansetron
BB 1101
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ondansetron (Oral soluble film OR injections) ,Dexamethasone
Description:
Participants will randomly assigned 1:1 to receive treatment (Oral soluble film of
Ondansetron plus dexamethasone OR Ondansetron injections plus dexamethasone).
Arm group label:
ondansetron intravenously combined with dexamethasone
Arm group label:
oral soluble film of ondansetron combined with dexamethasone
Other name:
Ondansetron，Dexamethasone
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.
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.
Criteria for 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.
Gender:
All
Minimum age:
6 Months
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi-Zhuo Zhang, MD
Phone:
87342460
Email:
zhangyzh@sysucc.org.cn
Start date:
July 9, 2023
Completion date:
January 31, 2027
Lead sponsor:
Agency:
Yizhuo Zhang
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06208917
