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Double-blind randomized phase III study comparing a mixture of natural agents versus placebo in the prevention of acute mucositis during chemoradiotherapy for head and neck cancer

2017; Wiley; Volume: 39; Issue: 9 Linguagem: Inglês

10.1002/hed.24832

1097-0347

Laura Marucci, Alessia Farneti, Paolo Di Ridolfi, Paola Pinnarò, Raul Pellini, Diana Giannarelli, Patrizia Vici, Mario Conte, Valeria Landoni, Giuseppe Sanguineti,

Cancer Diagnosis and Treatment

Head & NeckVolume 39, Issue 9 p. 1761-1769 ORIGINAL ARTICLE Double-blind randomized phase III study comparing a mixture of natural agents versus placebo in the prevention of acute mucositis during chemoradiotherapy for head and neck cancer Laura Marucci MD, Laura Marucci MD Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, ItalySearch for more papers by this authorAlessia Farneti MD, Alessia Farneti MD Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, ItalySearch for more papers by this authorPaolo Di Ridolfi RN, Paolo Di Ridolfi RN Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, ItalySearch for more papers by this authorPaola Pinnaro MD, Paola Pinnaro MD Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, ItalySearch for more papers by this authorRaul Pellini MD, Raul Pellini MD Department of Head and Neck Surgery, Regina Elena National Cancer Institute, Rome, ItalySearch for more papers by this authorDiana Giannarelli MD, Diana Giannarelli MD Department of Statistics, Regina Elena National Cancer Institute, Rome, ItalySearch for more papers by this authorPatrizia Vici MD, Patrizia Vici MD Department of Medical Oncology 2, Regina Elena National Cancer Institute, Rome, ItalySearch for more papers by this authorMario Conte MD, Mario Conte MD Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, ItalySearch for more papers by this authorValeria Landoni MD, Valeria Landoni MD Department of Physics, Regina Elena National Cancer Institute, Rome, ItalySearch for more papers by this authorGiuseppe Sanguineti MD, Corresponding Author Giuseppe Sanguineti MD giuseppe.sanguineti@ifo.gov.it orcid.org/0000-0001-6937-1406 Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, ItalyCorrespondence Giuseppe Sanguineti, Department of Radiation Oncology, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144 Rome, Italy. Email: giuseppe.sanguineti@ifo.gov.itSearch for more papers by this author Laura Marucci MD, Laura Marucci MD Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, ItalySearch for more papers by this authorAlessia Farneti MD, Alessia Farneti MD Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, ItalySearch for more papers by this authorPaolo Di Ridolfi RN, Paolo Di Ridolfi RN Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, ItalySearch for more papers by this authorPaola Pinnaro MD, Paola Pinnaro MD Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, ItalySearch for more papers by this authorRaul Pellini MD, Raul Pellini MD Department of Head and Neck Surgery, Regina Elena National Cancer Institute, Rome, ItalySearch for more papers by this authorDiana Giannarelli MD, Diana Giannarelli MD Department of Statistics, Regina Elena National Cancer Institute, Rome, ItalySearch for more papers by this authorPatrizia Vici MD, Patrizia Vici MD Department of Medical Oncology 2, Regina Elena National Cancer Institute, Rome, ItalySearch for more papers by this authorMario Conte MD, Mario Conte MD Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, ItalySearch for more papers by this authorValeria Landoni MD, Valeria Landoni MD Department of Physics, Regina Elena National Cancer Institute, Rome, ItalySearch for more papers by this authorGiuseppe Sanguineti MD, Corresponding Author Giuseppe Sanguineti MD giuseppe.sanguineti@ifo.gov.it orcid.org/0000-0001-6937-1406 Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, ItalyCorrespondence Giuseppe Sanguineti, Department of Radiation Oncology, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144 Rome, Italy. Email: giuseppe.sanguineti@ifo.gov.itSearch for more papers by this author First published: 31 May 2017 https://doi.org/10.1002/hed.24832Citations: 19Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract Background There is no widely accepted intervention in the prevention of acute mucositis during chemoradiotherapy for head and neck carcinoma. In the present double-blind study, we tested 4 natural agents, propolis, aloe vera, calendula, and chamomile versus placebo. Methods Patients undergoing concomitant chemo-intensity-modulated radiotherapy (IMRT) were given natural agent or matched placebo; grade 3 mucositis on physical examination according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was the primary endpoint. Various covariates were tested at logistic regression, including the individual amount of mucosa receiving at least 9.5 Gy per week (V9.5w). Results One hundred seven patients were randomized from January 2011 to July 2014, and 104 were assessable (51%-49% were assigned to the placebo group and 53%-51% were assigned to the natural agent). Overall, 61 patients developed peak grade 3 mucositis with no difference between arms (P = .65). Conversely, V9.5w (P = .007) and primary site (P = .037) were independent predictors. Conclusion The selected natural agents do not prevent mucositis, whereas the role of V9.5w is confirmed. Citing Literature Volume39, Issue9September 2017Pages 1761-1769 RelatedInformation