Laura Marucci1, Alessia Farneti1, Paolo Di Ridolfi1, Paola Pinnaro1, Raul Pellini2, Diana Giannarelli3, Patrizia Vici4, Mario Conte1, Valeria Landoni5, Giuseppe Sanguineti1. 1. Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, Italy. 2. Department of Head and Neck Surgery, Regina Elena National Cancer Institute, Rome, Italy. 3. Department of Statistics, Regina Elena National Cancer Institute, Rome, Italy. 4. Department of Medical Oncology 2, Regina Elena National Cancer Institute, Rome, Italy. 5. Department of Physics, Regina Elena National Cancer Institute, Rome, Italy.
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 undergoingconcomitant 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.
RCT Entities:
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.
Authors: Patrícia Leão Castillo Eubank; Lucas Guimaraes Abreu; Ivana Povoa Violante; Luiz Evaristo Ricci Volpato Journal: Support Care Cancer Date: 2021-05-14 Impact factor: 3.603
Authors: Odara Maria de Sousa Sá; Nilza Nelly Fontana Lopes; Maria Teresa Seixas Alves; Eliana Maria Monteiro Caran Journal: Nutrients Date: 2018-10-12 Impact factor: 5.717