Kozelsky 2003

Referenz

(Autor, Jahr, Journal)

Studientyp

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

Patientenmerkmale

Indikation, Alter, Geschlecht (m/w), CTX

Intervention

Kontrolle

Zielgröße

Primary Endpoint

Secondary Endpoint

Finanzierung

Evidenzstufe (CEBM levels/ SIGN)

Bei Abwertung: Angabe von Gründen

Kozelsky 2003

Journal of Clinical Oncology

Multicenter (14 Institutions)

Phase III, randomized, double-blind study

Two arms

N= 129

USA

02/1998-10/1999

Rectal, prostate, gynecologic cancers

69 (34-86) yrs.

m/f

N= 64

4 g Glutamine orally, twice a day (morning and evening), beginning with the first or second day of RT and continuing for 2 weeks after RT

N= 65

4 g Placebo (glycine) orally, twice a day (morning and evening), beginning with the first or second day of RT and continuing for 2 weeks after RT

Primary Endpoints: Incidence of Diarrhea, Maximum Grade of diarrhea and diarrhea score (NCI-CTCAE)

Any diarrhea (80 % vs. 79 %)

Grade 0 (20 % vs. 21 %)

Grade 1 (25 % vs. 29 %)

Grade 2 (34 % vs. 32 %)

Grade 3 (17 % vs. 16 %)

Grade 4 (3 % vs. 3 %)

Stools per day (mean number) physician reported (3.0 vs. 3.2)

Stools per day (mean number) patient reported (3.1 vs. 3.3)

No medication specific adverse events

Public Health Service Grants

1b/1+

 “There is no evidence of a beneficial effect of glutamine during pelvic RT.” (Radiotherapy)