Actively Recruiting
Ondansetron (ODF) Versus Ondansetron Intravenously for the Prevention of Chemotherapy-induced Nausea and Vomiting Compare in Children
Led by Yizhuo Zhang · Updated on 2024-01-17
376
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Ondansetron (ODF) Versus Ondansetron Intravenously for the Prevention of Chemotherapy-induced Nausea and Vomiting Compare in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 months to 18 years at the time of randomization
- Diagnosed with a solid tumor by cytological or histological examination
- Planned to start moderately or highly emetogenic chemotherapy
- Performance status score of 2 points or less
- Predicted life expectancy of 3 months or more and weight greater than 6 kilograms
- Parent or guardian has signed informed consent
You will not qualify if you...
- Vomited in the 24 hours before starting chemotherapy on Treatment Day 1
- Symptomatic primary or metastatic central nervous system malignancy with nausea and/or vomiting (asymptomatic patients may participate)
- Receiving stem cell rescue therapy within 14 days after ondansetron administration
- Received high emetic chemotherapy within two weeks
- Received or will receive total body irradiation to the abdomen or pelvis within one week before Treatment Day 1 or during the 120-hour diary reporting period
- Started benzodiazepine, opioid, or opioid-like therapy within 48 hours before study drug or expected to receive it within 120 hours after chemotherapy except single doses of midazolam, temazepam, or triazolam
- Started systemic corticosteroid therapy within 72 hours before study drug or expected to receive corticosteroids as part of chemotherapy
- Allergy to ondansetron or dexamethasone
- Active infection, congestive heart failure, bradyarrhythmia, or uncontrolled disease except malignancy
- Mentally incapacitated or significant emotional or psychiatric disorder
- History of QT prolongation or taking medication causing QT prolongation
- Abnormal liver function (ALT or AST ≥ 2 times normal) or abnormal renal function (serum creatinine ≥ 2.5 times normal)
- Taking or took within 48 hours before Treatment Day 1 any drugs with antiemetic properties such as 5-HT3 antagonists, benzamides, cyclizine, domperidone, herbal antiemetics, olanzapine, phenothiazines, or scopolamine
- Participated in a previous ondansetron study or took investigational drugs within the last 4 weeks
- Other situations where researchers believe participation is not appropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yizhuo Zhang
CONTACT
Y
Yizhuo Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here