Dodd 2003
Supportive Therapie · Version 2.1
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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 |
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Dodd
2003
CANCER INVESTIGATION |
randomized, double-blind clinical trial
n = 30
USA |
HNC who were initiating a course of RT to the oral cavity or pharynx
Age (SD) 53.7 y (18.1) vs. 56.6 y (13.0)
Gender: Female: 7 (50.0) vs. 2 (12.5) 0.05 Male: 7 (50.0) vs. 14 (87.5) |
Sucralfate n = 14
1g sucralfate /15 ml mouthwash
Salt & Soda n = 16 |
severity of the mucositis severity of mucositis-related pain time required to heal RT-induced mucositis |
Sucralfate vs. Salt & Soda
Time to heal (days) 70.8 (28.9) vs. 57.7 (22.5), p = 0.19
Worst-MacDibbs score 18.3 (4.2) vs. 17.9 (6.2), p = 0.85
Pain (swallowing) at worst MacDibbs score 2.1 (1.1) vs. 2.4 (0.9), p = 0.54 |
Presented at the 24th Annual Congress of the Oncology Nursing Society, Atlanta, Georgia, 1999. Funded by the Oncology Nursing Foundation, Sigma Theta Tau International, and the Research Center for Symptom Management (P30 NR03927) at the University of California, San Francisco School of Nursing |
2b small sample size - lack of statistical power no information anbout concealment method
"The findings from this trial provide important clinical information regarding cost analysis of RT mucositis management. Given that there is no significant difference in efficacy between micronized sucralfate and salt & soda, use of the less costly salt & soda is prudent and cost-effective." |