Kiliç 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

Kiliç 2000

Radiation and Oncology

Monocenter

Randomized, double-blind study

Two arms

N= 87

Turkey

08/1997-04/1999

Cancer in the pelvis without metastases beyond the regional lymph nodes

60 vs. 64 yrs.

m/f

46-50 Gy in 23-25 fractions

N= 44

Two tablets of Sulphasalazine (500 mg) twice daily, orally

N= 43

Two tablets of Placebo (colouring agent, talc, cellulose, purified water) twice daily, orally

Primary endpoint: incidence of diarrhea (according to NCI-CTCAE)

Secondary endpoint: LENT-SOMA score (summed score 0-2: 0, 3-9: 1, 10-18: 2, 19-27: 3, 28-36: 4)

Diarrhea during treatment, all grades (24/44 [55 %] vs. 37/43 [86 %])

Grade 0 (20/44 [46 %] vs. 6/43 [14 %])

Grade 1 (12/44 [27 %] vs. 16/43 [37 %])

Grade 2 (9/44 [20 %] vs. 8/43 [19 %])

Grade 3 (3/44 [7 %] vs. 6/43 [14 %])

Grade 4 (0/44 [0 %] vs. 7/43 [16 %])

LENT-SOMA

Grade 0 (9/44 [20 %] vs. 3/43 [7 %])

Grade 1 (29/44 [66 %] vs. 6/43 [14 %])

Grade 2 (6/44 [14 %] vs. 32/43 [74 %])

Grade 3 (0/44 [0 %] vs. 2/43 [4 %])

Grade 4 (0/44 [0 %] vs. 0/43 [0 %])

No complications due to the drug

No information

1b/1+

“Sulphasalazine (2g/day) was found to be effective in decreasing the symptoms of ARE.” (acute radiation enteritis)