---
title: "Megestrol Acetate Versus Dexamethasone to Prevent Nausea and Vomiting in Oxaliplatin-Based Chemo"
id: "bmj-open-4-megestrol-acetate-versus-dexamethasone-to-prevent-nausea-and-vomiting-in-patients-with-gastric-or-gastro-oesophageal-junction-cancer-treated-with-oxaliplatin-based-chemotherapy-study-protocol-of-a-multicentre-randomised-non-inferiority-trial"
canonical_url: "https://medichelpline.com/clinical-feed/bmj-open-4-megestrol-acetate-versus-dexamethasone-to-prevent-nausea-and-vomiting-in-patients-with-gastric-or-gastro-oesophageal-junction-cancer-treated-with-oxaliplatin-based-chemotherapy-study-protocol-of-a-multicentre-randomised-non-inferiority-trial"
content_type: "clinical_feed_article"
specialty: "Research Highlights"
source_name: "BMJ Open"
source_url: "http://bmjopen.bmj.com/cgi/content/short/16/4/e111001?rss=1"
published_at: "2026-04-03T13:57:55.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Megestrol Acetate Versus Dexamethasone to Prevent Nausea and Vomiting in Oxaliplatin-Based Chemo
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/bmj-open-4-megestrol-acetate-versus-dexamethasone-to-prevent-nausea-and-vomiting-in-patients-with-gastric-or-gastro-oesophageal-junction-cancer-treated-with-oxaliplatin-based-chemotherapy-study-protocol-of-a-multicentre-randomised-non-inferiority-trial
- **Specialty:** [Research Highlights](https://medichelpline.com/clinical-feed/research-highlights.md)
- **Primary Source:** BMJ Open
- **Source URL:** [Original Journal Publication](http://bmjopen.bmj.com/cgi/content/short/16/4/e111001?rss=1)
- **Published At:** 2026-04-03T13:57:55.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
Introduction Oxaliplatin is widely used in the treatment of gastric and gastro-oesophageal junction cancer. However, oxaliplatin-induced nausea and vomiting often complicate treatment and negatively affect patients' quality of life. The current standard antiemetic regimen - dexamethasone (DEX) plus palonosetron - offers only limited efficacy, benefiting approximately 70% of patients, and is associated with steroid-related adverse effects, including insomnia and gastrointestinal bleeding. Consequently, there is a clear clinical need for effective DEX-free antiemetic regimens. This study aims to evaluate the efficacy and safety of megestrol acetate versus DEX in preventing oxaliplatin-induced nausea and vomiting in patients with gastric or gastro-oesophageal junction cancer. Method and analysis This is an investigator-led, multicentre, randomised-controlled, open-label, phase III, non-inferiority trial. Chemotherapy-naïve patients scheduled to receive oxaliplatin-based chemotherapy are randomly (1:1) assigned to receive either megestrol acetate (megestrol acetate group) or DEX (DEX group) in combination with palonosetron. The primary endpoint is the complete response (CR; no vomiting and no rescue therapy) rate during the first 120 hours following the initiation of chemotherapy (0 - 120 hours).
## Clinical Analysis & Structured Key Points
A careful appraisal of study aims and design: - Objective and clinical question: - The trial seeks to determine whether megestrol acetate can match dexamethasone in preventing oxaliplatin-associated nausea and vomiting in patients with gastric or gastro-oesophageal junction cancer. - The motivation is to identify a DEX-free antiemetic option due to limited efficacy of the standard regimen (DEX plus palonosetron) and the adverse effects linked to dexamethasone. - Design and scope: - This is an investigator-led, multicentre, randomized, open-label, phase III study employing a non-inferiority framework. - Participants are chemotherapy-naïve and are assigned in a 1:1 ratio to either the megestrol acetate arm or the dexamethasone arm, both in combination with palonosetron. - The trial is structured to evaluate antiemetic performance within the context of oxaliplatin-based chemotherapy for gastric or gastro-oesophageal junction cancers. Context and primary endpoint: - Primary outcome: - Complete response (CR), defined as no vomiting and no need for rescue therapy, assessed during the first 120 hours (0–120 hours) after initiation of chemotherapy. - Secondary outcomes: - CR during the acute phase (0–24 hours) and the delayed phase (24–120 hours). - Time to treatment failure and frequency of salvage medication use. - Patient-reported and clinical safety metrics, including adverse events and quality of life. Population and intervention specifics: - Population: - Adults with gastric or gastro-oesophageal junction cancer planned to receive oxaliplatin-based chemotherapy. - The study targets individuals naïve to chemotherapy at enrollment. - Interventions: - Megestrol acetate group: megestrol acetate administered in combination with palonosetron. - DEX group: dexamethasone in combination with palonosetron. - Comparative framing: - The non-inferiority aim centers on whether megestrol acetate provides a CR comparable to dexamethasone across the specified time windows. Ethical and dissemination considerations: - Ethics: - The protocol adheres to the Declaration of Helsinki and has received ethics approval from the Certified Review Board of West China Hospital, Sichuan University (Approval No 1116/2023). - Dissemination plans: - Results are intended for presentation at scientific meetings and for publication in peer-reviewed journals. Context, limitations, and interpretive notes: - Evidentiary scope: - The content provided outlines study rationale, design, endpoints, and planned dissemination but does not include results, numerical data, or effect estimates. - Unreported elements: - Specific dosing regimens, the precise oxaliplatin-based regimens used, and anticipated sample size or statistical margins are not described in the text. - Long-term outcomes beyond 120 hours and detailed safety signals are not reported.
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