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 language | English |
|---|---|
| Article number | e27098 |
| Journal | Pediatric Blood and Cancer |
| Volume | 65 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - Aug 1 2018 |
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Keywords
- clinical trial
- laser
- mucositis
- pediatric hemato-oncology
- supportive care
ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health
- Hematology
- Oncology
Cite this
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, e27098, 01.08.2018.Research output: Contribution to journal › Article
}
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
PY - 2018/8/1
Y1 - 2018/8/1
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.
KW - clinical trial
KW - laser
KW - mucositis
KW - pediatric hemato-oncology
KW - supportive care
UR - http://www.scopus.com/inward/record.url?scp=85046368746&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85046368746&partnerID=8YFLogxK
U2 - 10.1002/pbc.27098
DO - 10.1002/pbc.27098
M3 - Article
AN - SCOPUS:85046368746
VL - 65
JO - Pediatric Blood and Cancer
JF - Pediatric Blood and Cancer
SN - 1545-5009
IS - 8
M1 - e27098
ER -