chemotherapy induced nausea and vomiting
Conditions
Interventions
A randomized comparison of standard of care 3-days (fos)aprepitant followed by
placebo (treatment regimen A) and (fos)aprepitant prophylaxis during the
complete course of chemotherapy (treatment reg
Sponsors
Prinses Máxima Centrum voor Kinderoncologie
Eligibility
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: these are the eligibility criteria: - Age must be >= 6 months to =6kg - a documented malignancy. - Patients need to receive moderate or highly emetogenic chemotherapy blocks, or chemotherapy not previously tolerated due to vomiting, for a minimum duration of 4 days. - Chemotherapy schedules need to contain two similar courses of chemotherapy, which do not necessarily have to be consecutive courses. - No symptomatic primary or metastatic CNS malignancy causing nausea or vomiting. - Patients do not receive scheduled blocks of chemotherapy containing dexamethasone as part of anti-tumour treatment during the study period. - Patients aged 16 and greater than 16y with a Karnofsky score of 60 or more or patients aged 15y or less with a Lansky Play performance score of 60 or more. - Patient must have a life expectancy of 3 months or more. - Patients must not use antiemetic treatment within 48h before treatment (see appendix B). - Patients must not receive radiation therapy to the abdomen or pelvis in the week before treatment. - Patient must not use benzodiazepines or opioids initiated within 48h before treatment, except for single doses of triazolam, temazepam, or midazolam. - Continuation of chronic benzodiazepine or opioid therapy is permitted provided it was initiated >=48 hours prior to study drug administration. o In patients on chronic warfarin, acenocoumarol, tolbutamide or phenytoin (metabolised by CYP2C9) therapy should be monitored closely during treatment with (fos)aprepitant and for 14 days following each course of (fos)aprepitant. o No use of CYP3A4 substrates/inhibitors within 7 days, or no CYP3A4 inducers within 30 days of treatment (see appendix B). - serum creatinine must be
Exclusion criteria
Exclusion criteria: see eligibility criteria D4a.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieve complete response (no vomiting, no retching and no use of rescue medication) during the 24-72 hours after the final dose of chemotherapy (delayed phase). | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who: - achieved complete response during the course of chemotherapy until 24h af-ter the final dose of chemotherapy (acute phase) - achieved complete response during both the acute and delayed phase (overall phase) Time from initiation of emetogenic chemotherapy to: o the first vomiting episode o the first rescue medication use Safety of prolonged use of (fos)aprepitant (AEs considered related by the investiga-tors) Pharmacokinetic (PK) parameters (i.e. clearance and volume of distribution) and in-fluencing PK co-variates as chemotherapeutics Improvement of CINV complaints according to the Pediatric Nausea Assessment tool (PeNAT) for children aged 4- | — |
Countries
Netherlands
Outcome results
None listed