Maddocks-Jennings 2009

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

Maddocks-Jennings

2009

European Journal of Oncology Nursing

randomized, placebo controlled feasibility study

n = 26

New Zealand

Australia

N = 19

head and neck cancers

Female: 5 pts

Male: 14 pt

Age: 68.9 y (range 45–81 years)

Active Group (AG) (n=9)

Received essential oil gargle

a gargle containing 2 drops of a 1:1 mix of the essential oils of manuka (Leptospermum scoparium) and kanuka (Kunzea ericoides) in water

Placebo Group (PG) (n=6)

Control group (CG) (n=8)

Received 'usual care' (n=8)

development of mucositis, pain and nutritional effects.

grade 1: 31.6% (6/19)

grade 2: 63% (12/19)

grade 3: 1 pts

time before a reaction occurred:

AG: mean radiation dose of 3120 cGy, 15.6 treatment days

PG: mean radiation dose of 1450 cGy, 7 treatment days

CG: mean radiation dose of 2163 cGy, 10.8 treatment days

AG vs. PG

AG vs. CG

p = 0.05

experience pain

scores ≥3

AG: 2 pts

CG: 5 pts

PG: 4 pts

until this level of pain was reached:

AG: 3600 cGy

CG: 3000 cGy

PG: 2100 cGy

weight loss

AG: 1% loss

CG: 2.5% loss

PG: 4.5% loss

-

2b

small sample size

timing of gargling in relation to eating, drinking or smoking was not explored

some individuals were unable to continue to participate in some treatment arms

"However a significant limitation in this study was the small sample size. Although the results from this feasibility study support the hypothesis that very small volumes of manuka and kanuka used in a gargle can provide a positive effect on the development of radiation induced mucositis, further research is required to confirm this finding. Randomization was applied according to the timing of the patient’s entering the trial as well as their physical ability to gargle. Confirmation of these findings would pave the way for introduction of a simple, yet effective treatment for a condition which causes considerable discomfort and for which there is currently no definitive treatment."