Vomiting after chemotherapy
Conditions
Interventions
fosaprepitant group versus aprepitant group:Children recruited to arm-A received intravenous ondansetron plus dexamethasone followed by fosaprepitant infusion. Children recruited to arm-B received the
Sponsors
Shanghai Children's Medical Center
Eligibility
Sex/Gender
All
Age
2 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. children aged 2-12 years at the time of study entry with documented cancer; 2. scheduled to receive MEC or HEC (more than 30% emetogenic potential); 3. with Karnofsky score of 60 or more (for patients aged greater than 10 years) or Lansky play performance score of 60 or more (for patients aged 10 years or less); 4. predicted life expectancy of at least 3 months; 5. written informed consent provided by parent or guardian.
Exclusion criteria
Exclusion criteria: 1. vomiting 24 h before treatment day 1; 2. known history of QT prolongation or allergic reaction to any of the study drugs; 3. symptomatic primary or metastatic CNS malignancy causing nausea or vomiting; 4. patients who received radiation therapy to the abdomen or pelvis in the week before treatment; 5. active infection or any uncontrolled concurrent illness except for malignancy; 6. abnormal laboratory values at screening (peripheral absolute neutrophil count 5 ULN, bilirubin or serum creatinine >1.5 ULN); 8. initiation of systemic corticosteroids within 72 h before study drug administration or as part of the chemotherapy regimen; 9. benzodiazepines or opioids initiated within 48 h before treatment, except for single doses of triazolam, temazepam, or midazolam; 10. use of antiemetics within 48 h of treatment; 11. use of CYP3A4 substrates or inhibitors within 7 days or CYP3A4 inducers within 30 days of treatment; 12. and pregnant or breast feeding patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of vomiting; | — |
Countries
China
Contacts
Public ContactLi-Ting Yu
Shanghai Children's Medical Center
Outcome results
None listed