Carter 1999

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

Carter

1999

Head Neck

double blind randomized trial

N = 102

USA

high dose radiation therapy (RT) for head and neck cancer

mean (+/-SD) prescribed dose was 69 +/- 7 Gy.

69 pts received BID fractionation and 27 pts received concurrent chemotherapy.

sucralfate ( n = 52) vs placebo (n= 50)

Time to…

weight loss, mucositis, pain, nutritional intake, and need for a treatment break.

No difference was detected in any outcome measure in the direct comparison between the two groups.

On multivariate analysis, weight loss >5% or >10% occurred more frequently in patients receiving chemotherapy (p < 0.01 and p = 0.05, respectively).

Grade 3 mucositis was more common in patients receiving chemotherapy (p = 0.05) or BID fractionation (p = 0.04) or having a poor KPS (p = 0.02).

Interval to healing was not associated with any of the pretreatment- or treatment-related factors.

Sucralfate did not result in any additional toxicity.

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1b

"Prophylactic treatment with sucralfate during high-dose head and neck RT did not decrease acute treatment side effects. Other modalities should be investigated."