Abstract
Chemotherapy induced nausea and vomiting (CINV) is one of the common complications experienced by patients and affects up to 40% of patients receiving chemotherapy. Most Guidelines (ASCO, NCCN, and MASCC/ESMO) recommend the use of triple drug or 4 drug antiemetic regimens for prevention of CINV caused by highly emetogenic chemotherapy (HEC) i.e 5HT3 receptor antagonist, steroids, NK receptor antagonist and olanzapine. Both oral as well as intravenous antiemetics are recommended. However, no head to head trials are available to compare efficacy of oral vs intravenous ondansetron and dexamethasone combination for prevention of CINV in treatment naïve newly diagnosed cancer patients. Therefore, we conducted a randomized, phase III, open label non inferiority study to evaluate the efficacy of oral vs intravenous ondansetron and dexamethasone in prevention of chemotherapy induced nausea and vomiting in newly diagnosed cancer patients receiving 1st cycle of highly emetogenic chemotherapy. This study initiated in March 2023. A total of 210 patients are planned to be enrolled over a period of 1.5 years. The study has been registered with clinical trial registry of India (CTRI/2024/03/063697).