Nuchit 2019

Supportive Therapie · Version 2.1

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

Nuchit

 

2019

 

Supportive Care in Cancer

single-blinded randomized controlled trial

 

3 centre

 

N = 73

 

Thailand

 

11/2017 – 11/2018

post-radiation head and neck cancer patients with xerostomia

 

N = 62

 

Study group (OMJ) (n =

31)

 

Age, mean ± SD (year): 55.5 ± 9.3

 

Sex, n (%)

Male: 22 (71.0)

Female: 9 (29.0)

 

Control group (GC) (n =

31)

 

Age, mean ± SD (year): 55.5 ± 10.5

 

Sex, n (%)

Male: 20 (64.5)

Female: 11 (35.5)

 

Study group (OMJ) (n =

31)

 

daily swallow 1–2 teaspoons of OMJ six times per day (every 3 h) for 2 months

Study group (OMJ) (n =

31)

 

topically apply a pea-sized drop of GC dry mouth gel to oral cavity six times per day (every 3 h) for 2 months

Subjective dry mouth score

 

Objective dry mouth score

 

Subjective swallowing problem score

 

Objective swallowing ability score

 

Clinical nutritional status

 

Body weight and body mass index

 

Energy intake

After 1 and 2 months of interventions:

subjective and objective dry mouth scores, subjective swallowing problem scores, swallowing times, and clinical nutritional status in both groups were significantly improved (p < 0.0001).

 

Compared to GC, OMJ

group had higher percent improvement in all outcome measures (p < 0.001) except swallowing time and clinical nutritional status.

 

subjective dry mouth scores were significantly correlated with subjective swallowing problem scores (r = 0.5321, p < 0.0001).

This work was supported by Dental Innovation Foundation under Royal Patronage (DIF), a non-profit organization. The funder provided financial support and OMJ samples but did not involve in experimental design, data collection, and data analysis.

2

single blinded
no infromation about concealment method
no placebo control
swallowing of OMJ
topical apply of GC without spitting out
different radiation doses

 

"Continuous uses of saliva substitutes (OMJ or GC) for at least a month improved signs and symptoms of dry mouth and enhanced swallowing ability. An edible saliva substitute was superior to a topical saliva gel for alleviating dry mouth and swallow problems. These lead to improved clinical nutritional status. Thus, palliation of dry mouth may be critical to support nutrition of post-radiotherapy head and neck cancer patients."