Efficacy of Aprepitant (Emend®) in Children

Sponsor

University of Oklahoma (Other)

Overall Status

Completed

CT.gov ID

NCT01661335

Collaborator

(none)

Enrollment

Location

Arms

60.9

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Nausea Vomiting Childhood Cancer	Drug: Ondansetron, dexamethasone, aprepitant Drug: Ondansetron, Dexamethasone, placebo	Phase 3

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

Efficacy of Aprepitant (Emend®) in Children Receiving Highly Emetogenic Chemotherapy

Actual Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Jun 29, 2017

Actual Study Completion Date :

Jun 29, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ondansetron, dexamethasone, aprepitant Arm A: 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.	Drug: Ondansetron, dexamethasone, aprepitant 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. Other Names: Aprepitant = Emend ARM A
Placebo Comparator: Ondansetron, Dexamethasone, placebo Arm B: 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%.	Drug: Ondansetron, Dexamethasone, placebo 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%. Other Names: ARM B

Arm

Intervention/Treatment

Experimental: Ondansetron, dexamethasone, aprepitant

Arm A: 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.

Drug: Ondansetron, dexamethasone, aprepitant

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.

Other Names:

Aprepitant = Emend

ARM A

Placebo Comparator: Ondansetron, Dexamethasone, placebo

Arm B: 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%.

Drug: Ondansetron, Dexamethasone, placebo

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%.

Other Names:

ARM B

Outcome Measures

Primary Outcome Measures

Efficacy of aprepitant (Emend®) measured through a complete response [Up to 11 weeks, or until 3 weeks after the second course of the study regimen]
• 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.
Efficacy of aprepitant (Emend®) measured through episodes of emesis and use of rescue medication. [Up to 11 weeks, or until 3 weeks after the second course of the study regimen]
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.
Efficacy of aprepitant (Emend®) measured through impact of chemotherapy induced nausea and vomiting on daily life [Up to 11 weeks, or until 3 weeks after the second course of the study regimen]
• A modified, 5-day recall version of the Functional Living Index-Emesis (FLIE) questionnaire
Efficacy of aprepitant (Emend®) measured through a pictorial nausea scale [Up to 11 weeks, or until 3 weeks after the second course of the study regimen]
• A modified version of the Baxter Animated Retching Faces (BARF) scale, administered daily.

Secondary Outcome Measures

Safety of aprepitant (Emend®) [Up to 11 weeks, or until 3 weeks after the second course of the study regimen]
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.