Kawashita 2019

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

Kawashita

2019

Int J Oral Maxillofac Surg

multicentre, phase II, randomized controlled trial

5 centre

124 patients

Japan

oral cancer receiving radiotherapy alone or chemoradiotherapy

radiotherapy N = 37 pts

intervention group (n=18): oral care + spacers to cover the entire dentition, pilocarpine hydrochloride, and topical dexamethasone ointment

control group (n=19):

chemoradiotherapy:87 pts

intervention group (n=42) and control group (n=45).

control group: only oral care

intervention group: oral care + spacers to cover the entire dentition, pilocarpine hydrochloride, and topical dexamethasone ointment

effectiveness of a comprehensive oral management protocol for the prevention of severe oral mucositis

The intervention was significantly associated with a decreased incidence of severe oral mucositis in patients receiving radiotherapy alone (P=0.046), but not in those receiving chemoradiotherapy (P=0.815).

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3

open-label, multicentre trial: no blinding
numerous regimens; small number of pts with the same regime

"These findings suggest that an oral management protocol can prevent severe oral mucositis in patients with oral cancer undergoing radiotherapy without concurrent chemotherapy."