Veness 2006

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

Veness

2006

Australasian Radiology

double-blind, randomized, placebo-controlled trial

n = 83 pts

Australia

1999 - 2002

mucosal squamous cell carcinoma (SCC) of the head and

neck

Misoprostol (n = 42) vs. Placebo (n = 41)

Mean age in years (range) 57 (39–81) vs. 57 (21–77)

Men 33 vs. 28

Concurrent chemotherapy 16 vs. 15

Current smoker 8 vs.9

Altered fractionation 1vs.  1

Mean total dose of radiation (Gy)

63.6 vs. 62.2

Misoprostol: n = 42 pts

Placebo: n = 41 pts

Primary end-points:

extent of grade 3 mucositis

incidence and the duration of mucositis.

Secondary end-points: time to the development of mucositis

extent of grade 2 mucositis

Patient weight

General well-being

Incidence of radiation-induced mucositis

Severity of mucositis as measured by area under the curve

Misoprostol vs. Placebo

Mean 13.2 vs. 16.6 p = 0.1

Oropharyngeal/oral soreness and quality of life

Oropharyngeal/oral soreness and general well-being

Misoprostol vs. Placebo

Soreness

Mean 7.6 vs. 6.9, p = 0.04

General well-being

Mean 5.8 vs. 5.2,  p = 0.3

Weight loss and hospital admission

Weight loss from baseline

Misoprostol (%) vs. Placebo (%)

Mean 11.6 vs. 11.1

The authors would like to thank Pfizer Australia Pty Ltd for their

generous support in supplying the study drug and placebo.

2b

no information about concealment method
endpoint failed
slow accrual
12% rate of patient withdrawals
failure to reach a target sample size of 70 patients in each arm

"In conclusion, we were unable to identify a reduction in radiation-induced mucositis in patients receiving misoprostol. There is a paucity of high-level evidence on potentially useful interventions and a continued need for new and innovative research, incorporating quality-of-life measurements, in patients experiencing radiation-induced mucositis."