Robjins_2021

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

Robjins

2021

Radiotherapy and Oncology

randomised, placebo-controlled trial (RCT)

multicentric

n = 65

Belgium

01/2016 – 01/2020

head and neck cancer

(HNC) patients

radiotherapy (RT) with or without concomitant chemotherapy

PBM group

Age (years): 64.06 (11.78)

Body Mass Index (BMI): 25.79 (5.68)

Gender

Male: 23 (82.1%)

Female: 5 (17.9%)

Control group

Age (years): 65.06 (10.37)

Body Mass Index (BMI): 25.79 (5.68)

Gender

Male: 16 (88.9%)

Female 2 (11.1%)

N = 28

photobiomodulation therapy (PBMT) from the first day of RT (2x/week) along-side the institutional skincare

N =18

placebo treatments from the first day of RT (2x/week) along-side the institutional skincare

Skin toxicity grading - Radiation-Induced Skin Reaction Assessment Scale

(RISRAS)

Quality of life

control vs. PBM group

RT dose of 40 Gy:

grade 1 skin reaction: 70.6% vs. 84%

end of RT (60-70 Gy): number of severe skin reactions (grade 2–3) increased significantly (p = 0.01) in the control group

PBM group: development of acute radiation dermatitis (ARD) remained stable (p = 0.21)

end of RT - skin toxicity :

77.8% vs. 28.6%, p = 0.002

PBM group: lower median RISRAS scores than the control group at both RT dose 40 Gy and the end of RT - not statistically significant

QoL

No significant differences were detected (RT dose of 40 Gy and at the end of RT)

This research is part of the Limburg Clinical Research Center (LCRC)

UHasselt-ZOL-Jessa, financially supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish Government, Hasselt University, Ziekenhuis Oost-Limburg, and Jessa Hospital. Additionally, this research project is funded by Kom op tegen Kanker (Stand up to Cancer), the Flemish Cancer Society, Limburgs Kankerfonds, and ASA Srl.

2

62 patients were needed to detect significant differences between the two groups

19 patients were lost to follow-up

"The results of the first RCT in HNC patients showed that PBMT is an effective method to prevent the development of severe ARD. These results support the implementation of PBM in the clinical oncology – radiotherapy practice."