A phase III, randomized, open label non inferiority study to evaluate the efficacy of oral Ondansetron and Dexamethasone vs intravenous Ondansetron and Dexamethasone in prevention of chemotherapy induced nausea and vomiting in patients receiving highly emetogenic chemotherapy (HEC)- ONDEXCEL TRIAL.

A phase III, randomized, open label non inferiority study to evaluate the efficacy of oral Ondansetron and Dexamethasone vs intravenous Ondansetron and Dexamethasone in prevention of chemotherapy induced nausea and vomiting in patients receiving highly emetogenic chemotherapy (HEC)- ONDEXCEL TRIAL. | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article A phase III, randomized, open label non inferiority study to evaluate the efficacy of oral Ondansetron and Dexamethasone vs intravenous Ondansetron and Dexamethasone in prevention of chemotherapy induced nausea and vomiting in patients receiving highly emetogenic chemotherapy (HEC)- ONDEXCEL TRIAL. Gurmeet Kaur, Akash Jha, Ajay Gogia, Atul Batra, Sameer Bakhshi, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4372230/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version 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). ondansetron dexamethasone CINV efficacy Full Text Supplementary Files SPIRITchecklist2.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4372230","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":318237992,"identity":"2d96a794-19c2-46b4-8763-eb0a3ef6f843","order_by":0,"name":"Gurmeet Kaur","email":"","orcid":"","institution":"All India Institute of Medical Sciences Department of Medical Oncology","correspondingAuthor":false,"prefix":"","firstName":"Gurmeet","middleName":"","lastName":"Kaur","suffix":""},{"id":318237993,"identity":"e352ea98-c655-4921-b226-63ac82ab4d9e","order_by":1,"name":"Akash Jha","email":"","orcid":"","institution":"All India Institute of 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