The purpose of this study is to find out whether or not adding aprepitant(Emend®) to the standard therapy will help children who receive chemotherapy to have less nausea and vomiting.
1.1 Primary Aim To determine the efficacy of aprepitant (Emend®) in preventing and reducing chemotherapy-induced nausea and vomiting (CINV) when added to standard antiemetic drug regimens for children receiving highly emetogenic chemotherapy. The working hypothesis will be that standard therapy + aprepitant is superior at preventing CINV than standard therapy + placebo. 1.2 Secondary Aim To evaluate the safety and toxicity of aprepitant (Emend®) in children receiving highly emetogenic chemotherapy when compared to standard antiemetic therapy + placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
19
Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no longer than 5 days; dexamethasone 0.2mg/kg (max 10 mg) IV or PO daily for at least 3 days, but no longer than 5 days; and aprepitant 3 mg/kg (max 125 mg) PO on day 1, and aprepitant 2 mg/kg (max 80 mg) PO on days 2 and 3 during the first investigational antiemetic cycle. During the next investigational antiemetic cycle, members of this arm will be crossed-over into the placebo arm, where the aprepitant will be replaced by placebo and the dexamethasone dose will be increased to 0.4 mg/kg (max 20 mg) daily.
Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no more than 5 days; dexamethasone 0.4 mg/kg (max 20 mg) IV or PO daily for at least 3 days, but no more than 5 days; and a PO placebo for 3 days during the first investigational antiemetic cycle. During the second cycle, members this group will be crossed-over to the experimental arm, where the placebo will be replaced by aprepitant and the dexamethasone will be decreased by 50%.
Jimmy Everest Center for Cancer and Blood Disorders in Children
Oklahoma City, Oklahoma, United States
Efficacy of aprepitant (Emend®) measured through a complete response
• Percentage of study subjects who demonstrate a complete response, defined as no episodes of emesis and no use of rescue medications during the investigational antiemetic cycles.
Time frame: Up to 11 weeks, or until 3 weeks after the second course of the study regimen
Efficacy of aprepitant (Emend®) measured through episodes of emesis and use of rescue medication.
* The total episodes of emesis within 7 days of the first chemotherapy administration of each cycle. * The total number of administrations of rescue medications given for breakthrough nausea or vomiting.
Time frame: Up to 11 weeks, or until 3 weeks after the second course of the study regimen
Efficacy of aprepitant (Emend®) measured through impact of chemotherapy induced nausea and vomiting on daily life
• A modified, 5-day recall version of the Functional Living Index-Emesis (FLIE) questionnaire
Time frame: Up to 11 weeks, or until 3 weeks after the second course of the study regimen
Efficacy of aprepitant (Emend®) measured through a pictorial nausea scale
• A modified version of the Baxter Animated Retching Faces (BARF) scale, administered daily.
Time frame: Up to 11 weeks, or until 3 weeks after the second course of the study regimen
Safety of aprepitant (Emend®)
* Occurrence of adverse events as per the NCI Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. These will be reported spontaneously or on inquiry by the investigator/study nurse, and continuously monitored throughout the trial. * Weekly complete blood count (CBC) for 3 weeks after each investigational antiemetic cycle. * Weekly complete metabolic profile (CMP) for 3 weeks after each investigational antiemetic cycle.
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Time frame: Up to 11 weeks, or until 3 weeks after the second course of the study regimen