{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T18:20:15Z","timestamp":1789237215795,"version":"build-2803163510"},"reference-count":32,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2019,11,13]],"date-time":"2019-11-13T00:00:00Z","timestamp":1573603200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["81602070"],"award-info":[{"award-number":["81602070"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2020,1]]},"abstract":"Abstract<\/jats:title>Background<\/jats:title>Monosialotetrahexosylganglioside (GM<\/jats:styled-content>1) is a neuroprotective glycosphingolipid that repairs nerves. Oxaliplatin\u2010based chemotherapy is neurotoxic. This study assessed the efficacy of GM1 for preventing oxaliplatin\u2010induced peripheral neurotoxicity (OIPN<\/jats:styled-content>) in colorectal cancer (CRC<\/jats:styled-content>) patients receiving oxaliplatin\u2010based chemotherapy.<\/jats:p><\/jats:sec>Methods<\/jats:title>In total, 196 patients with stage II\/III CRC<\/jats:styled-content> undergoing adjuvant chemotherapy with mFOLFOX<\/jats:styled-content>6 were randomly assigned to intravenous GM<\/jats:styled-content>1 or a placebo. The primary endpoint was the rate of grade 2 or worse cumulative neurotoxicity (NCI<\/jats:styled-content>\u2010CTCAE<\/jats:styled-content>). The secondary endpoints were chronic cumulative neurotoxicity (EORTC<\/jats:styled-content> QLQ<\/jats:styled-content>\u2010CIPN<\/jats:styled-content>20), time to grade 2 neurotoxicity (NCI<\/jats:styled-content>\u2010CTCAE<\/jats:styled-content> or the oxaliplatin\u2010specific neuropathy scale), acute neurotoxicity (analog scale), rates of dose reduction or withdrawal due to OIPN<\/jats:styled-content>, 3\u2010year disease\u2010free survival (DFS<\/jats:styled-content>) and adverse events.<\/jats:p><\/jats:sec>Results<\/jats:title>There were no significant differences between the arms in the rate of NCI<\/jats:styled-content>\u2010CTCAE<\/jats:styled-content> grade 2 or worse neurotoxicity (GM<\/jats:styled-content>1: 33.7% vs placebo: 31.6%; P\u00a0=\u00a0<\/jats:italic>.76) or neuropathy measured by the EORTC<\/jats:styled-content> QLQ<\/jats:styled-content>\u2010CIPN<\/jats:styled-content>20 or time to grade 2 neurotoxicity using NCI<\/jats:styled-content>\u2010CTCAE<\/jats:styled-content> and the oxaliplatin\u2010specific neuropathy scale. GM<\/jats:styled-content>1 substantially decreased participant\u2010reported acute neurotoxicity (sensitivity to cold items [P<\/jats:italic>\u00a0<\u00a0.01], discomfort swallowing cold liquids [P<\/jats:italic>\u00a0<\u00a0.01], throat discomfort [P<\/jats:italic>\u00a0<\u00a0.01], muscle cramps [P<\/jats:italic>\u00a0<\u00a0.01]). The rates of dose reduction or withdrawal were not significantly different between the arms (P\u00a0=\u00a0<\/jats:italic>.08). The 3\u2010year DFS<\/jats:styled-content> rates were 85% and 83% in the GM<\/jats:styled-content>1 and placebo arms, respectively (P<\/jats:italic>\u00a0=\u00a0.19). There were no differences in toxicity between the arms.<\/jats:p><\/jats:sec>Conclusion<\/jats:title>Patients receiving GM<\/jats:styled-content>1 were less troubled by the symptoms of acute neuropathy. However, we do not support the use of GM<\/jats:styled-content>1 to prevent cumulative neurotoxicity. (ClinicalTrials.gov<\/jats:ext-link> number, NCT02251977).<\/jats:p><\/jats:sec>","DOI":"10.1002\/cam4.2693","type":"journal-article","created":{"date-parts":[[2019,11,14]],"date-time":"2019-11-14T06:37:08Z","timestamp":1573713428000},"page":"151-159","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["Phase III randomized, placebo\u2010controlled, double\u2010blind study of monosialotetrahexosylganglioside for the prevention of oxaliplatin\u2010induced peripheral neurotoxicity in stage II\/III colorectal cancer"],"prefix":"10.1002","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9657-4380","authenticated-orcid":false,"given":"De\u2010shen","family":"Wang","sequence":"first","affiliation":[{"name":"State Key Laboratory of Oncology in South China Collaborative Innovation Center for Cancer Medicine Department of Medical Oncology Sun Yat\u2010sen University Cancer Center Guangzhou 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