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 trial.

Conditions

Delayed chemotherapy induced nausea and vomiting (CINV)

Brief summary

The proportion of patients who achieved complete response (defined as no vomiting, no retching and no use of rescue medication) during the >24-72 hours after the final dose of chemotherapy (delayed phase).

Detailed description

Proportion of patients who: - achieved complete response during the course of chemotherapy until 24h after 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: 1. the first vomiting episode 2. the first rescue medication use, Safety of prolonged use of (fos)aprepitant (AEs considered related by the investigators)., Pharmacokinetic (PK) parameters (i.e. clearance and volume of distribution) and influ-encing PK co-variates as chemotherapeutics., Improvement of CINV complaints according to the Pediatric Nausea Assessment tool (PeNAT) and the Baxter Retching Faces (BARF)., Validity, responsiveness and feasibility of PeNAT and BARF., Cost-effectiveness of prolonged (fos)aprepitant dosing regimen.

Related papers

No related papers found yet.

Interventions

DRUGAprepitant Placebo Tablet

DRUGAprepitant Teva 80 mg

DRUGharde capsules

DRUGNaCl I.V.

DRUGIVEMEND 150 mg powder for solution for infusion

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The proportion of patients who achieved complete response (defined as 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 after 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: 1. the first vomiting episode 2. the first rescue medication use, Safety of prolonged use of (fos)aprepitant (AEs considered related by the investigators)., Pharmacokinetic (PK) parameters (i.e. clearance and volume of distribution) and influ-encing PK co-variates as chemotherapeutics., Improvement of CINV complaints according to the Pediatric Nausea Assessment tool (PeNAT) and the Baxter Retching Faces (BARF)., Validity, responsiveness and feasibility of PeNAT and BARF., Cost-effectiveness of prolonged (fos)aprepitant dosing regimen.	—

Measure

Time frame

Proportion of patients who: - achieved complete response during the course of chemotherapy until 24h after 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: 1. the first vomiting episode 2. the first rescue medication use, Safety of prolonged use of (fos)aprepitant (AEs considered related by the investigators)., Pharmacokinetic (PK) parameters (i.e. clearance and volume of distribution) and influ-encing PK co-variates as chemotherapeutics., Improvement of CINV complaints according to the Pediatric Nausea Assessment tool (PeNAT) and the Baxter Retching Faces (BARF)., Validity, responsiveness and feasibility of PeNAT and BARF., Cost-effectiveness of prolonged (fos)aprepitant dosing regimen.

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Countries

Netherlands

Outcome results

None listed