The relevance for childhood cancer in the light of this current pilot study is very clear. Prophylaxis on chemotherapy induced nausea and vomiting is still a major problem in children receiving highly emetogenic therapy. Compared to adults we achieve almost 30% less control of CINV in children. This emphasizes the urgent need for novel strategies in the prophylaxis of CINV in children. With these study results we can build a PK model which will be used for the optimization of the aprepitant and
Conditions
Interventions
None listed
Sponsors
Princess Maxima Center for pediatric oncology
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Planned to receive chemotherapy intravenously as regular treatment (standard of care); 2. Receiving granisetron/ondansetron; dexamethasone and/or aprepitant as standard of care 3. Age ≥ 6 months and ≤ 18 years; 4. Signed Informed consent form (ICF) prior to participation in the study; 5. A present central line to sample blood for pharmacokinetics; 6. No Down syndrome or other syndromes that may influence regular dosing or no other disease/circumstances that may influence the participation of the subject in a negative way; 7. No use of strong CYP3A4 substrates or inhibitors within 7 days or CYP3A4 inducers within 30 days of treatment (appendix 2)
Exclusion criteria
Exclusion criteria: see eligibility criteria above
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to define the recommended dose of aprepitant given in combination with dexamethasone by constructing a population PK model in children according to different age groups | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The feasibility of using the validated PeNAT score on nausea intensity in clinical practice 2. To describe possible interaction of dexamethasone and aprepitant with concurrent chemotherapy | — |
Outcome results
None listed