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
Article numbere27098
JournalPediatric Blood and Cancer
Volume65
Issue number8
DOIs
Publication statusPublished - Aug 1 2018

Keywords

  • clinical trial
  • laser
  • mucositis
  • pediatric hemato-oncology
  • supportive care

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Hematology
  • Oncology

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    Gobbo, M., Verzegnassi, F., Ronfani, L., Zanon, D., Melchionda, F., Bagattoni, S., Majorana, A., Bardellini, E., Mura, R., Piras, A., Petris, M. G., Mariuzzi, M. L., Barone, A., Merigo, E., Decembrino, N., Vitale, M. C., Berger, M., Defabianis, P., Biasotto, M., ... Zanazzo, G. A. (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, 65(8), [e27098]. https://doi.org/10.1002/pbc.27098