DAVINCY (all cancer types)
Active, not recruiting
Who can enter
Children with cancer who are being treated with chemotherapy
Age: from 6 months through 18 years old
Goal
Goal
(Fos)aprepitant is an anti-nausea medication. The goal of this study is to see whether giving (fos)aprepitant longer works better in preventing chemotherapy-induced nausea and vomiting. We will also determine whether giving (fos)aprepitant longer is safe. In addition, we will explore which questionnaire is most appropriate to measure the severity of nausea.
Background
Background
Nausea and vomiting caused by chemotherapy is one of the most common side effects in pediatric cancer treatment. The children are given supportive medication for this. However, in half of the children these side effects are not well controlled.
(Fos)aprepitant is a drug for nausea caused by chemotherapy. Aprepitant is given in a capsule. Fosaprepitant is the same drug, but is given by infusion.
(Fos)aprepitant is registered (approved) as a 3-day course, even if chemotherapy lasts longer and nausea persists even after three days. No previous study in children has examined whether this is the optimal treatment duration and thus whether it may be more effective to give aprepitant longer.
In this study, we will compare a treatment duration of 3 days with giving (fos)aprepitant throughout the duration of chemotherapy (4 to 8 days). With the result of the study, we hope to say whether giving (fos)aprepitant longer is safe and more effective against nausea and vomiting caused by chemotherapy.
Last reviewed
Last reviewed
April 7, 2026
Study details
- Study details
Official title
DAVINCY trial: optimal Duration of (fos)Aprepitant prophylaxis for nausea and Vomiting INduced by ChemotherapY in children: a double-blind placebo-controlled crossover randomized phase III trialCancer type
All typesPhase
3Maximum number of patients
76Start date
December 21, 2021Status
Gesloten voor deelnameLocal principal investigator
Dr. E. de Vos-KerkhofSponsor
Princess Máxima Center for pediatric oncologyApproval
The study of this new treatment has been reviewed by an accredited medical research ethics committee. This committee has decided that it is justified to ask patients to participate in this study. More information can be found at: CCMO.Trial registry number
EU Clinical Trial Register: 2021-003311-26
The above information is intended as a brief summary only and may not reflect the most up-to-date information. For full details and the current status of a protocol, physicians can contact the Princess Máxima Center directly.