Martenson 2000

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

Martenson 2000

Journal of Clinical Oncology

Monocenter

Randomized, double-blind study

Two arms

N=123

USA

04/1996-05/1997

Cancer in the pelvis without distant metastases

m/f

45 Gy, 1.7-2.1 Gy per day

N= 62

500 mg Sucralfate orally every 6 h, continued for duration of treatment unless grade 3 or worse diarrhea occurred

N= 61

500 mg Placebo (cellulase) orally every 6 h, continued for duration of treatment unless grade 3 or worse diarrhea occurred

Primary Endpoints: Frequency and severity of RT-induced diarrhea

Secondary Endpoints:

Bleeding, tenesmus, constipation, abdominal cramping

Diarrhea

Grade 0 (16/62 [26 %] vs. 17/61 [28 %])

Grade 1 (13/62 [21 %] vs. 19/61 [31 %])

Grade 2 (22/62 [35 %] vs. 14/61 [23 %])

Grade 3 (8/62 [13 %] vs. 9/61 [15 %])

Grade 4 (3/62 [5 %] vs. 2/61 [3 %])

All grades (46/62 vs. 44/61)

Fecal incontinence (21/62 [34 %] vs. 10/61 [16 %]) p=0.04

Need for protective clothing or pad (14/62 [23 %] vs. 5/61 [8 %]) p=0.04

Nausea

Grade 0 (52/62 [84 %] vs. 59/61 [97 %])

Grade 1 (7/62 [11 %] vs. 1/61 [2 %])

Grade 2 (3/62 [5 %] vs. 0/61 [0 %])

Grade 3 (0/62 [0 %] vs. 1/61 [2 %])

In part by public health service grants from the National Cancer Institute Department of Health and Human Services, Bethesda, MD

1b/1+

Missing data: age

“Sucralfate did not decrease pelvic RT-related bowel toxicity by any of the end points measured and seems to have aggravated some gastrointestinal symptoms.