Study to Evaluate Anti-emetic Effect of Aprepitant Versus Placebo in Children and Adolescent Receiving Chemotherapy
Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
Chemotherapy induced nausea and vomiting (CINV) is one of the few mostly observed distressing
toxicity of cancer treatment. It can occur up to 90% in case of highly emetogenic
chemotherapy use. CINV causes disturbance in daily living of cancer patient and reduces
compliance with treatment Even with the standard anti-emetic measures up to 50% patient can
suffer from this complication. Whereas there is standard anti-emetic guideline exists in case
of adult patients, there no such guidelines made in pediatric population. The new drug
Aprepitant has been recommended for use in adults with high efficacy, there no such concrete
data available in children regarding its use. There are few retrospective reports and limited
data available regarding use of Aprepitant in children with satisfactory efficacy in reducing
CINV. As there no randomized large data to suggests its efficacy and its routine use in
children, we have planned this study.
Phase:
Phase 3
Details
Lead Sponsor:
All India Institute of Medical Sciences, New Delhi