Abstract
Background: Chemotherapy induced nausea and vomiting (CINV) is the commonest and the most incapacitating experience of thepatient undergoing cancer chemotherapy. Poorly controlled CINV sometimes make patients to refuse further treatment. This study aimed to compare the efficacy and safety of Palonosetron and Ondansetron in preventing CINV during cancer chemotherapy. Methods:This randomized controlled trial was conducted in the Department of Pharmacology and Therapeutics of Sylhet MAG Osmani Medical College from January 2021 to December 2021. There were 190patients enrolled initially; 14 patients from both groups withdraw themselves. Finally, 91 patients of Palonosetron and 85 patients of Ondansetron treated were recruited. The Palonosetron group were treated with Palonosetron at 0.25 mg and the Ondansetron group were treated with Ondansetron 8.0 mg intravenously, 30min before chemotherapy. After that Palonosetron 0.5 mg single time and Ondansetron 8.0 mg orally three times a day were given and total follow-up period was seven days. Episode of nausea and vomiting graded according to the guideline “Common Terminology Criteria for Adverse Events (CTCAE)”, version 4.0, which was published by the US Department of Health and Human Services (National Institute of Health and National Cancer Institute). Result: The groups were matched for the age (p = 0.263), gender (p = 0.630), body weight (p = 0.846),site of malignancy (p = 0.375), and drugsused for chemotherapeutic (p = 0.301) in both study groups. Palonosetron treated patients experienced significant lower episode of nausea in day-1 (p = <0.001) and day-2 (p = 0.025), and in case vomiting in day-1 (p = 0.026) compared to Ondansetron. Significantly higher number of patients of Palonosetron compared to Ondansetron treated group showed complete response in both acute phase (p = 0.026), delayed phase (p = 0.036) and finally in overall phase (p = 0.014). Only four patients experienced with treatment failure in Ondansetron treated group. Observed adverse effects were in low intensity and not caused to stop the treatment procedure. Conclusion: Palonosetron was found to be more efficacious and well tolerated in preventing acute, delayed and overall phase of chemotherapy induced nausea and vomiting in this study.
Published Version
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