Kauark-Fontes 2022

Referenz

(Autor, Jahr, Journal)

Studientyp

Mono- vs. Multizentrisch, Verblindung, Randomisierung, Arme, Fallzahl n, Land, Zeitraum

Patienten-merkmale

Indikation, Alter, Geschlecht (m/w)

Intervention

Fallzahl n, Beschreibung der präventiven bzw. therapeutischen Maßnahme

Kontrolle

Fallzahl n, Beschreibung der präventiven Maßnahme bzw. therapeutischen Maßnahme

Zielgrößen

Primärer Endpunkt

Sekundäre(r) Endpunkt(e)

Primärer Endpunkt

Angaben für Intervention vs. Kontrolle

Sekundäre(r) Endpunkt(e)

Angaben für Intervention vs. Kontrolle

Finanzierung

Evidenzstufe

Bei Abwertung: Angabe von Gründen

Bewertung des Autors

Kauark-Fontes

2022

Supportive Care in Cancer

randomized, double‑blind, clinical trial

n = 55

Brazil

USA

06/2019 -

11/2020

oropharyngeal squamous cell carcinoma (OOPSCC) stage III or IVwith radiotherapy (RT)

PBM: 29

Placebo: 26

Gender

Male

PBM:  3 (79.3%)

Placebo: 22 (84.6%)

Female

PBM: 6 (20.7%)

Placebo:  4 (15.4%)

Age (years)

Mean ± SD PBM: 59.5 (± 8.1)

Placebo: 62.1 (± 8.7)

Prophylactic extraoral PBM

daily prophylactic PBM for 5 consecutive days/week (Monday to Friday),

from the first to the last day of RT

vs. placebo

safety and efficacy of prophylactic extraoral photobiomodulation (PBM) for the prevention of oral and oropharyngeal mucositis (OM)

first occurrence of OM: at week 1, for the placebo

group (p = 0.014)

at week 2 for the PBM (p = 0.009).

No difference in severe OM incidence (p > 0.05)

Lower mean pain at week 7: PBM group: 2.1

placebo group: 4.5

p = 0.009

for the PBM group:

less analgesics

week 3; p = 0.009

week 7; p = 0.02

less anti-inflammatory prescription

week 5; p = 0.0346)

better QoL scores at last day of RT p = 0.0034

No difference in overall survival among groups was observed in 1 year of follow-up (p = 0.889).

This trial had the financial support of the São Paulo Research

Foundation (FAPESP) processes numbers 2018/02233–6

and 2018/23479–3, and the National Council for Scientific

and Technological Development (CNPq)

2

interims analysis

"Prophylactic extraoral PBM can delay OM onset, reduce pain, and reduce analgesic and anti-inflammatory prescription requirements. Extraoral PBM was associated with better QoL. There was no evidence of PBM impact on oncological outcomes."