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. Issue 8 (4th May 2018)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: Pediatric blood & cancer. Volume 65:Issue 8(2018)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2018-05-04
• Subjects: clinical trial -- laser -- mucositis -- pediatric hemato‐oncology -- supportive care; Tumors in children -- Periodicals; Blood -- Diseases -- Periodicals; Cancer in children -- Periodicals; 618.92
• DOI: 10.1002/pbc.27098
• Languages: English
• ISSNs: 1545-5009

Abstract

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.