Study to evaluate the antiemetic efficacy of ginger root extract capsules for children adolescents and young adults receiving highly emetogenic chemotherapy A Seamless Placebo controlled single centre combined Phase II and III Randomized Controlled Trial

Chemotherapy-induced nausea and vomiting (CINV) affects 40–70% of pediatric patients—over twice the risk seen in adults—despite antiemetic prophylaxis, which can reduce treatment adherence and increase hospitalization costs. Current guidelines recommend 5-HT3 receptor antagonists and dexamethasone for acute CINV in children, but research on pediatric cases remains limited, and no standard guidelines exist for delayed CINV. This highlights the need for additional or alternative treatments to manage CINV in children, adolescents, and young adults effectively. In a double-blind placebo-controlled trial, we have previously demonstrated that ginger-root-extract-capsules improve nausea and vomiting for children receiving cisplatin-containing chemotherapy. Several trials have demonstrated the efficacy of ginger in preventing CINV in adults. However, the proper dose and standardization of formulation are not yet well explored, and there is a lack of enough evidence to suggest statistically significant benefits in children, adolescents, and young adults.

There is a notable lack of research and well-conducted clinical trials on effective interventions for managing CINV in pediatric oncology. This study aims to bridge this gap by investigating the use of ginger capsules to alleviate nausea and vomiting in children, adolescents, and young adults receiving highly emetogenic chemotherapy. As a widely available, safe, and well- tolerated natural remedy, ginger offers a good option. This trial seeks to evaluate its efficacy in preventing CINV in children, adolescents, and young adults, adolescents, and young adults. If proven effective, ginger-root-extract-capsules could become a cost-effective, accessible, and practical option for managing CINV.