Multicenter randomized, double-blind controlled trial to evaluate the efficacy of laser therapy for the treatment of severe oral mucositis induced by chemotherapy in children: laMPO RCT

Margherita Gobbo, Federico Verzegnassi, Luca Ronfani, Davide Zanon, Fraia Melchionda, Simone Bagattoni, Alessandra Majorana, Elena Bardellini, Rosamaria Mura, Alessandra Piras, Maria Grazia Petris, Maria Livia Mariuzzi, Angelica Barone, Elisabetta Merigo, Nunzia Decembrino, Marina Consuelo Vitale, Massimo Berger, Patrizia Defabianis, Matteo Biasotto, Giulia OttavianiGiulio Andrea Zanazzo

Research output: Contribution to journalArticle

Abstract

OBJECTIVES: To demonstrate the efficacy of laser photobiomodulation (PBM) compared to that of placebo on severe oral mucositis (OM) in pediatric oncology patients. The primary objective was the reduction of OM grade (World Health Organization [WHO] scale) 7 days after starting PBM. Secondary objectives were reduction of pain, analgesic consumption, and incidence of side effects.

METHODS: One hundred and one children with WHO grade > 2 chemotherapy-induced OM were enrolled in eight Italian hospitals. Patients were randomized to either PBM or sham treatment for four consecutive days (days +1 to +4). On days +4, +7, and +11, OM grade, pain (following a 0-10 numeric pain rating scale, NRS) and need for analgesics were evaluated by an operator blinded to treatment.

RESULTS: Fifty-one patients were allocated to the PBM group, and 50 were allocated to the sham group. In total, 93.7% of PBM patients and 72% of sham patients had OM grade < 3 WHO on day +7 (P = 0.01). A significant reduction of pain was registered on day +7 in the PBM versus sham group (NRS 1 [0-3] vs. 2.5 [1-5], P < 0.006). Reduced use of analgesics was reported in the PBM group, although it was not statistically significant. No significant adverse events attributable to treatment were recorded.

CONCLUSIONS: PBM is a safe, feasible, and effective treatment for children affected by chemotherapy-induced OM, as it accelerates mucosal recovery and reduces pain.

Original languageEnglish
Pages (from-to)e27098
JournalPediatric Blood and Cancer
Volume65
Issue number8
DOIs
Publication statusPublished - Aug 2018

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Stomatitis
Laser Therapy
Drug Therapy
Pain
Analgesics
Therapeutics
Placebos
Lasers
Pediatrics
Incidence

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Multicenter randomized, double-blind controlled trial to evaluate the efficacy of laser therapy for the treatment of severe oral mucositis induced by chemotherapy in children : laMPO RCT. / Gobbo, Margherita; Verzegnassi, Federico; Ronfani, Luca; Zanon, Davide; Melchionda, Fraia; Bagattoni, Simone; Majorana, Alessandra; Bardellini, Elena; Mura, Rosamaria; Piras, Alessandra; Petris, Maria Grazia; Mariuzzi, Maria Livia; Barone, Angelica; Merigo, Elisabetta; Decembrino, Nunzia; Vitale, Marina Consuelo; Berger, Massimo; Defabianis, Patrizia; Biasotto, Matteo; Ottaviani, Giulia; Zanazzo, Giulio Andrea.

In: Pediatric Blood and Cancer, Vol. 65, No. 8, 08.2018, p. e27098.

Research output: Contribution to journalArticle

Gobbo, M, Verzegnassi, F, Ronfani, L, Zanon, D, Melchionda, F, Bagattoni, S, Majorana, A, Bardellini, E, Mura, R, Piras, A, Petris, MG, Mariuzzi, ML, Barone, A, Merigo, E, Decembrino, N, Vitale, MC, Berger, M, Defabianis, P, Biasotto, M, Ottaviani, G & Zanazzo, GA 2018, 'Multicenter randomized, double-blind controlled trial to evaluate the efficacy of laser therapy for the treatment of severe oral mucositis induced by chemotherapy in children: laMPO RCT', Pediatric Blood and Cancer, vol. 65, no. 8, pp. e27098. https://doi.org/10.1002/pbc.27098
Gobbo, Margherita ; Verzegnassi, Federico ; Ronfani, Luca ; Zanon, Davide ; Melchionda, Fraia ; Bagattoni, Simone ; Majorana, Alessandra ; Bardellini, Elena ; Mura, Rosamaria ; Piras, Alessandra ; Petris, Maria Grazia ; Mariuzzi, Maria Livia ; Barone, Angelica ; Merigo, Elisabetta ; Decembrino, Nunzia ; Vitale, Marina Consuelo ; Berger, Massimo ; Defabianis, Patrizia ; Biasotto, Matteo ; Ottaviani, Giulia ; Zanazzo, Giulio Andrea. / Multicenter randomized, double-blind controlled trial to evaluate the efficacy of laser therapy for the treatment of severe oral mucositis induced by chemotherapy in children : laMPO RCT. In: Pediatric Blood and Cancer. 2018 ; Vol. 65, No. 8. pp. e27098.
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title = "Multicenter randomized, double-blind controlled trial to evaluate the efficacy of laser therapy for the treatment of severe oral mucositis induced by chemotherapy in children: laMPO RCT",
abstract = "OBJECTIVES: To demonstrate the efficacy of laser photobiomodulation (PBM) compared to that of placebo on severe oral mucositis (OM) in pediatric oncology patients. The primary objective was the reduction of OM grade (World Health Organization [WHO] scale) 7 days after starting PBM. Secondary objectives were reduction of pain, analgesic consumption, and incidence of side effects.METHODS: One hundred and one children with WHO grade > 2 chemotherapy-induced OM were enrolled in eight Italian hospitals. Patients were randomized to either PBM or sham treatment for four consecutive days (days +1 to +4). On days +4, +7, and +11, OM grade, pain (following a 0-10 numeric pain rating scale, NRS) and need for analgesics were evaluated by an operator blinded to treatment.RESULTS: Fifty-one patients were allocated to the PBM group, and 50 were allocated to the sham group. In total, 93.7{\%} of PBM patients and 72{\%} of sham patients had OM grade < 3 WHO on day +7 (P = 0.01). A significant reduction of pain was registered on day +7 in the PBM versus sham group (NRS 1 [0-3] vs. 2.5 [1-5], P < 0.006). Reduced use of analgesics was reported in the PBM group, although it was not statistically significant. No significant adverse events attributable to treatment were recorded.CONCLUSIONS: PBM is a safe, feasible, and effective treatment for children affected by chemotherapy-induced OM, as it accelerates mucosal recovery and reduces pain.",
author = "Margherita Gobbo and Federico Verzegnassi and Luca Ronfani and Davide Zanon and Fraia Melchionda and Simone Bagattoni and Alessandra Majorana and Elena Bardellini and Rosamaria Mura and Alessandra Piras and Petris, {Maria Grazia} and Mariuzzi, {Maria Livia} and Angelica Barone and Elisabetta Merigo and Nunzia Decembrino and Vitale, {Marina Consuelo} and Massimo Berger and Patrizia Defabianis and Matteo Biasotto and Giulia Ottaviani and Zanazzo, {Giulio Andrea}",
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TY - JOUR

T1 - Multicenter randomized, double-blind controlled trial to evaluate the efficacy of laser therapy for the treatment of severe oral mucositis induced by chemotherapy in children

T2 - laMPO RCT

AU - Gobbo, Margherita

AU - Verzegnassi, Federico

AU - Ronfani, Luca

AU - Zanon, Davide

AU - Melchionda, Fraia

AU - Bagattoni, Simone

AU - Majorana, Alessandra

AU - Bardellini, Elena

AU - Mura, Rosamaria

AU - Piras, Alessandra

AU - Petris, Maria Grazia

AU - Mariuzzi, Maria Livia

AU - Barone, Angelica

AU - Merigo, Elisabetta

AU - Decembrino, Nunzia

AU - Vitale, Marina Consuelo

AU - Berger, Massimo

AU - Defabianis, Patrizia

AU - Biasotto, Matteo

AU - Ottaviani, Giulia

AU - Zanazzo, Giulio Andrea

N1 - © 2018 Wiley Periodicals, Inc.

PY - 2018/8

Y1 - 2018/8

N2 - OBJECTIVES: To demonstrate the efficacy of laser photobiomodulation (PBM) compared to that of placebo on severe oral mucositis (OM) in pediatric oncology patients. The primary objective was the reduction of OM grade (World Health Organization [WHO] scale) 7 days after starting PBM. Secondary objectives were reduction of pain, analgesic consumption, and incidence of side effects.METHODS: One hundred and one children with WHO grade > 2 chemotherapy-induced OM were enrolled in eight Italian hospitals. Patients were randomized to either PBM or sham treatment for four consecutive days (days +1 to +4). On days +4, +7, and +11, OM grade, pain (following a 0-10 numeric pain rating scale, NRS) and need for analgesics were evaluated by an operator blinded to treatment.RESULTS: Fifty-one patients were allocated to the PBM group, and 50 were allocated to the sham group. In total, 93.7% of PBM patients and 72% of sham patients had OM grade < 3 WHO on day +7 (P = 0.01). A significant reduction of pain was registered on day +7 in the PBM versus sham group (NRS 1 [0-3] vs. 2.5 [1-5], P < 0.006). Reduced use of analgesics was reported in the PBM group, although it was not statistically significant. No significant adverse events attributable to treatment were recorded.CONCLUSIONS: PBM is a safe, feasible, and effective treatment for children affected by chemotherapy-induced OM, as it accelerates mucosal recovery and reduces pain.

AB - OBJECTIVES: To demonstrate the efficacy of laser photobiomodulation (PBM) compared to that of placebo on severe oral mucositis (OM) in pediatric oncology patients. The primary objective was the reduction of OM grade (World Health Organization [WHO] scale) 7 days after starting PBM. Secondary objectives were reduction of pain, analgesic consumption, and incidence of side effects.METHODS: One hundred and one children with WHO grade > 2 chemotherapy-induced OM were enrolled in eight Italian hospitals. Patients were randomized to either PBM or sham treatment for four consecutive days (days +1 to +4). On days +4, +7, and +11, OM grade, pain (following a 0-10 numeric pain rating scale, NRS) and need for analgesics were evaluated by an operator blinded to treatment.RESULTS: Fifty-one patients were allocated to the PBM group, and 50 were allocated to the sham group. In total, 93.7% of PBM patients and 72% of sham patients had OM grade < 3 WHO on day +7 (P = 0.01). A significant reduction of pain was registered on day +7 in the PBM versus sham group (NRS 1 [0-3] vs. 2.5 [1-5], P < 0.006). Reduced use of analgesics was reported in the PBM group, although it was not statistically significant. No significant adverse events attributable to treatment were recorded.CONCLUSIONS: PBM is a safe, feasible, and effective treatment for children affected by chemotherapy-induced OM, as it accelerates mucosal recovery and reduces pain.

U2 - 10.1002/pbc.27098

DO - 10.1002/pbc.27098

M3 - Article

C2 - 29727048

VL - 65

SP - e27098

JO - Pediatric Blood and Cancer

JF - Pediatric Blood and Cancer

SN - 1545-5009

IS - 8

ER -