{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,3]],"date-time":"2026-04-03T16:00:14Z","timestamp":1775232014140,"version":"3.50.1"},"reference-count":38,"publisher":"BMJ","issue":"4","license":[{"start":{"date-parts":[[2026,4,3]],"date-time":"2026-04-03T00:00:00Z","timestamp":1775174400000},"content-version":"unspecified","delay-in-days":2,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100013365","name":"West China Hospital, Sichuan University","doi-asserted-by":"publisher","award":["No. 2023HXFH037"],"award-info":[{"award-number":["No. 2023HXFH037"]}],"id":[{"id":"10.13039\/501100013365","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,2,20]]},"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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\u2019 quality of life. The current standard antiemetic regimen\u2014dexamethasone (DEX) plus palonosetron\u2014offers 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Method and analysis<\/jats:title>\n                    <jats:p>This is an investigator-led, multicentre, randomised-controlled, open-label, phase III, non-inferiority trial. Chemotherapy-na\u00efve 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\u2013120\u2009hours). Secondary endpoints include the following indicators: CR rate in acute period (0\u201324\u2009hours), CR rate in delayed period (24\u2013120\u2009hours), time to treatment failure, frequency of salvage medication use, nausea, anorexia, adverse events and quality of life.<\/jats:p>\n                    <jats:p>The study will evaluate the efficacy and safety of megestrol acetate compared with DEX for prevention of oxaliplatin-induced nausea and vomiting in patients with gastric or gastro-oesophageal junction cancer. If proven effective, the results might inform future antiemetic strategies in the long term to (1) provide a novel DEX-free antiemetic treatment for prevention of moderate-emetogenic chemotherapy, (2) reduce DEX-related adverse effects and improve quality of life in patients with gastric or gastro-oesophageal junction cancer and (3) support the potential incorporation of megestrol acetate into standard antiemetic medications.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study protocol is conducted in accordance with the Declaration of Helsinki and approved by the Certified Review Board of West China Hospital, Sichuan University (Ethics Approval No 1116\/2023). The results of this study will be disseminated via presentations at national and international scientific conferences and publication in peer-reviewed journals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ChiCTR2300075943.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-111001","type":"journal-article","created":{"date-parts":[[2026,4,3]],"date-time":"2026-04-03T15:20:16Z","timestamp":1775229616000},"page":"e111001","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["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"],"prefix":"10.1136","volume":"16","author":[{"given":"Haiyan","family":"Luo","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, West China Hospital of Sichuan University, Chengdu, China"},{"name":"Gastric Cancer Center, Sichuan University West China Hospital, Chengdu, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qiancheng","family":"Hu","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, West China Hospital of Sichuan University, Chengdu, China"},{"name":"Gastric Cancer Center, Sichuan University West China Hospital, Chengdu, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lianli","family":"Zeng","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, West China Hospital of Sichuan University, Chengdu, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qiyue","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, The Sixth People\u2019s Hospital of Chengdu, Chengdu, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuhao","family":"Luo","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Affiliated Hospital of Southwest Medical University, Luzhou, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ting","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, West China (Airport) Hospital Sichuan University (The First People's Hospital of Chengdu), Chengdu, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ping","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, The Seventh People\u2019s Hospital of Chengdu, Chengdu, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5963-5751","authenticated-orcid":false,"given":"Cheng","family":"Yi","sequence":"additional","affiliation":[{"name":"Abdominal Oncology Ward, West China Hospital of Medicine, Chengdu, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2071-6773","authenticated-orcid":false,"given":"Hongfeng","family":"Gou","sequence":"additional","affiliation":[{"name":"Gastric Cancer Center, Sichuan University West China Hospital, Chengdu, China"},{"name":"Sichuan University West China Hospital, Chengdu, China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2026,4,3]]},"reference":[{"key":"2026040308200923000_16.4.e111001.1","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.2014-0438"},{"key":"2026040308200923000_16.4.e111001.2","first-page":"5339","article-title":"A retrospective study on chemotherapy-induced nausea and vomiting in highly\/moderately emetogenic chemotherapy: incidence and prescribing practice","volume":"30","author":"Badarudin","year":"2022","journal-title":"Support Care Cancer"},{"key":"2026040308200923000_16.4.e111001.3","doi-asserted-by":"publisher","DOI":"10.1016\/j.esmoop.2023.102195"},{"key":"2026040308200923000_16.4.e111001.4","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.20.01296"},{"key":"2026040308200923000_16.4.e111001.5","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1515442"},{"key":"2026040308200923000_16.4.e111001.6","unstructured":"Network NCC . 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