Moller_2018

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

Møller

2018

Technical Innovations & Patient Support in Radiation

Oncology

intra-patient randomized multicentre study

3 centre

N = 101

Denmark

10/2015 – 02/2016

breast cancer patients

postoperative adjuvant radiotherapy

hypo-fractionated breast radiotherapy based on 40 Gy/15 fractions in 3 weeks

Age, mean: 61.9 (range 31–82)

BMI, mean: 26.5

lateral part of the chest was covered by Mepitel film

medial part of the chest was covered by Mepitel film

primary endpoint: patient reported symptoms and experience

secondary endpoint: radiotherapy staff evaluation of dermatitis

Mepitel film vs. Standard care

skin area covered by film: lower level of pain (p < 0.001), itching (p = 0.005), burning sensation (p = 0.005), edema (p = 0.017) and reduced sensitivity (p < 0.001).

Most patients (76%) would have preferred film on the entire treatment area (p < 0.001) and Mepitel Film as a standard treatment option (84%) (p < 0.001). Patients treated after mastectomy had a significantly lower severity of radiation-induced dermatitis with film at the end of RT compared to standard care (p = 0.005). However, in the blinded staff evaluation, no significant differences

were found at follow-up

Observer-rated radiodermatitis

Last day of RT (n = 76)

Mepitel film

Standard care

Grade 0: 24 (31%) vs. 21 (28%)

Grade 1: 47 (62%) vs. 44 (58%)

Grade 2: 5 (7%) vs. 10 (13%)

Grade 3: 0 vs. 1 (1%)

P=0.100

14 days after RT (n = 79)

Mepitel film

Standard care

Grade 0: 20 (25%) vs. 20 (25%)

Grade 1: 53 (67%) vs. 49 (62%)

Grade 2: 6 (8%) vs. 10 (13%)

Grade 3: 0 vs. 0

P=0.493

The authors declare no conflict of interest.

2

dropouts were not included in the final analyses
12 pts dropped out due to skin rash
drop-out rate was very different among
the centers

"Patients reported reduced symptoms from the skin with Mepitel Film and the majority would have preferred film as a standard offer to cover their entire treatment area. Especially women treated after mastectomy had a significantly lower level of radiodermatitis and preferred the film over standard care."