Vidal-Casariego 2014

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

Vidal-Casariego 2014

Journal of Parenteral and Enteral Nutrition

Monocenter

Double-blind, randomized, controlled trial

Two arms

N= 69

Spain

Pelvic or abdominal malignancies

64.9±9.7 vs. 68.1±10.0 yrs.

m/f

21.6 Gy vs. 25 Gy

N= 34

Glutamin (30 g/d) 3 sachets á 10 g per day, dissolved in 200 ml water, drunk after meal

3 days before the start of the RT until completion of RT

N= 35

Placebo Casein (30 g/d) 3sachets á 10 g per day, dissolved in 200 ml water, drunk after meal

3 days before the start of the RT until completion of RT

Intestinal toxicity classified according RTOG (Radiation Therapy Oncology Group) criteria

Visit 2 (in the middle of RT-Treatment) (p= 0.001)

Diarrhea

Grade 0 (19/34 [55.9 %] vs. 33/35 [93.9 %])

Grade 1 (8/34 [23.5 %] vs. 2/35 [6.1 %])

Grade 2 (7/34 [20.6 %] vs. 0/35 [0 %])

No Grade 3-4 diarrhea

No differences in adverse-events between both groups

Glutamine-treatment was well tolerated, four patients in the control-group stopped treatment due to vomiting

No information

1b/1+

“Glutamine does not prevent the development of enteritis during RT.”