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

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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.
Original languageEnglish
Pages (from-to)1761-1769
Number of pages9
JournalHead and Neck Surgery
Volume39
Issue number9
DOIs
Publication statusPublished - 2017

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Mucositis
Chemoradiotherapy
Head and Neck Neoplasms
Placebos
Calendula
Chamomile
Aloe
Propolis
Intensity-Modulated Radiotherapy
Double-Blind Method
Terminology
Physical Examination
Mucous Membrane
Arm
Neck
Logistic Models
Head
Carcinoma

Keywords

  • chemotherapy
  • head and neck cancer
  • mucositis
  • natural agents
  • prophylaxis
  • radiotherapy

Cite this

@article{7e10e7ad79a84770a95f634667e4032a,
title = "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",
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.",
keywords = "chemotherapy, head and neck cancer, mucositis, natural agents, prophylaxis, radiotherapy",
author = "L. Marucci and A. Farneti and Ridolfi, {P. Di} and P. Pinnaro and R. Pellini and D. Giannarelli and P. Vici and M. Conte and V. Landoni and G. Sanguineti",
note = "LR: 20170531; CI: (c) 2017; JID: 8902541; OTO: NOTNLM; 2016/11/28 [received]; 2017/02/09 [revised]; 2017/04/17 [accepted]; aheadofprint",
year = "2017",
doi = "10.1002/hed.24832 [doi]",
language = "English",
volume = "39",
pages = "1761--1769",
journal = "Head and Neck Surgery",
issn = "1043-3074",
publisher = "Wiley-Liss Inc.",
number = "9",

}

TY - JOUR

T1 - 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

AU - Marucci, L.

AU - Farneti, A.

AU - Ridolfi, P. Di

AU - Pinnaro, P.

AU - Pellini, R.

AU - Giannarelli, D.

AU - Vici, P.

AU - Conte, M.

AU - Landoni, V.

AU - Sanguineti, G.

N1 - LR: 20170531; CI: (c) 2017; JID: 8902541; OTO: NOTNLM; 2016/11/28 [received]; 2017/02/09 [revised]; 2017/04/17 [accepted]; aheadofprint

PY - 2017

Y1 - 2017

N2 - 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.

AB - 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.

KW - chemotherapy

KW - head and neck cancer

KW - mucositis

KW - natural agents

KW - prophylaxis

KW - radiotherapy

U2 - 10.1002/hed.24832 [doi]

DO - 10.1002/hed.24832 [doi]

M3 - Article

VL - 39

SP - 1761

EP - 1769

JO - Head and Neck Surgery

JF - Head and Neck Surgery

SN - 1043-3074

IS - 9

ER -