Last updated: January 16, 2024
Sponsor: Yizhuo Zhang
Overall Status: Active - Recruiting
Phase
3
Condition
Vomiting
Treatment
Ondansetron (Oral soluble film OR injections) ,Dexamethasone
Clinical Study ID
NCT06208917
SunYat-senU-ondansetron
Ages 6-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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
Exclusion
Exclusion Criteria:
- 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 withnausea and/or vomiting (asymptomatic participants may participate in study) ;
- Will be receiving stem cell rescue therapy within 14 days following administration ofondansetron ;
- Has experienced High emetic chemotherapy within two weeks ;
- Has received or will receive total body irradiation to the abdomen or pelvis in theweek prior to Treatment Day 1 and/or during the diary reporting period (120 hoursfollowing initiation of chemotherapy) ;
- Has had benzodiazepine, opioid or opioid like therapy initiated within 48 hours priorto study drug administration, or is expected to receive within 120 hours followinginitiation of chemotherapy except for single doses of midazolam, temazepam ortriazolam ;
- Has started on systemic corticosteroid therapy within 72 hours prior to study drugadministration or is expected to receive a corticosteroid as part of the chemotherapyregimen ;
- 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 tolead to QT prolongation ;
- Abnormal liver function (alanine aminotransferase or aspartate aminotransferase ≥ 2times 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 followingdrugs with antiemetic properties: 5-hydroxytryptamine 3 (5-HT3) antagonists (e.g.,ondansetron), benzamides (e.g., haloperidol), cyclizine, domperidone, herbal therapieswith 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 aninvestigational drug with the last 4 weeks ;
- other situations in which the researchers believe that they cannot be included in thegroup.
Study Design
Total Participants: 376
Treatment Group(s): 1
Primary Treatment: Ondansetron (Oral soluble film OR injections) ,Dexamethasone
Phase: 3
Study Start date:
July 09, 2023
Estimated Completion Date:
January 31, 2027
Study Description
Connect with a study center
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaActive - Recruiting
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