Martenson 1996

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 1996

Int J Radiation Oncology Biol Phys

Monocenter

Randomized, placebo-controlled study

Two arms

N= 58

USA

08/1993-02/1994

Cancer in the pelvis, without mestastases beyond regional lymph nodes

68.1 vs. 69.8 yrs.

m/f

Total irradiation 45-53.5 Gy, daily 1.7-2.1 Gy

N=30

250 mg olsalazine, two capsules twice daily

N=28

250 mg placebo, two capsules twice daily

Primary Endpoint: Diarrhea

Secondary Endpoint: rectal bleeding, abdominal cramping, tenesmus

Diarrhea

Grade 0 (6/30 [20 %] vs. 7/28 [25 %])

Grade 1 (4/30 [13 %] vs. 10/28 [36 %])

Grade 2 (2/30 [7 %] vs. 7/28 [25 %])

Grade 3 (7/30 [23 %] vs. 4/28 [14 %])

Grade 4 (11/30 [37 %] vs. 0/28 [0 %])

Study closed early, because prelimnary analysis showed excessive diarrhea in patients randomized to olsalazine

Public Health Service Grants, Grants from the National Cancer Institute

1b/1+

“Administration of olsalazine during pelvid radiation therapy resulted in an increased incidence and severity of diarrhea. Olsalazine is contraindicated in patients receiving pelvic radiation therapy”