Childhood Cancer, Nausea, Vomiting
Conditions
Keywords
Nausea, Vomiting, Children, Aprepitant, Emend®
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.
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.
Interventions
DRUGOndansetron, 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.
DRUGOndansetron, 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%.
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 20 Years
Healthy volunteers
No
Inclusion criteria
under 20.99 years of age at enrollment Scheduled to receive two identical cycles of highly emetogenic\[1\] chemotherapy for treatment of a primary malignancy, including: Chemotherapy with any one or more of the following single agents in any combination: * Carboplatin * Carmustine \>250 mg/m2 * Cisplatin * Cyclophosphamide ≥1 g/m2 * Dactinomycin * High dose Methotrexate ≥ 5 g/m2 Or any of the following defined combinations: * Cyclophosphamide + anthracycline * Cyclophosphamide + etoposide * Cytarabine 150-200 mg/m2 + daunorubicin * Cytarabine 300 mg/m2 + etoposide * Cytarabine 300 mg/m2 + teniposide * Doxorubicin + ifosfamide * Doxorubicin + methotrexate 5 g/m2 * Etoposide + ifosfamide
Exclusion criteria
* Patients who have received aprepitant in the past. * Patients who demonstrate evidence of increased intracranial pressure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed