Morais 2020

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

Morais

2020

Supportive Care in Cancer

Prospective cohort

N = 61

Brazil

2016 and 2017

head and neck cancer patients undergoing radiochemotherapy

mean age: 58.6 (SD = 9.9)

male: 49 (80.3%)

smokers: 52 (85.2%)

alcohol consumers weekly: 44 (72.1%)

POCP (oral hygiene and plaque control, removal of infection foci, dental restorations, periodontal therapy, fluorotherapy, oral hydration, and denture removal at night)  combined with daily PBMT.

severity of oral mucositis (OM)

oral symptoms (pain, solid and fluid dysphagia, odynophagia, dysgeusia)

quality of life impacts

interruptions of radiotherapy (RT) due to symptoms

Disease-free

overall survival

rates

oral assessment guide (OAG)

1st examination (after consent to participate): 10 (2.0)

2nd examination (1st RT session): 10 (4.0)

3rd examination (15th RT session): 12 (2.0)*

*Statistically significant difference (Wilcoxon test)—1st examination compared with the 2nd and 3rd

Examinations

“Patient Reported Oral Mucositis Symptom Scale” (PROMS)

RT sessions

Initial: 0.0 (10.0)

7th: 10.0 (23.0)*

14th: 21.5 (28.0)*

21st: 23.5 (30.0)

30th: 28.3 (30.0)

Pain

RT sessions

Initial: 0.0 (0.0)

7th: 0.0 (3.0)*

14th: 0.3 (5.0)

21st: 0.0 (5.0)

30th: 0.7 (5.0)

*p < 0.05—Wilcoxon test for pairwise comparison between each RT session and the previous session

The authors wish to thank the Hospital Araújo Jorge – Combat Cancer Association (HAJ-ACCG) and Foundation for Research Support of the State of Goiás (DECIT/SCTIE/MS/CNPq/ FAPEG - Protocol 12/2013; process 201410267000312)

3

no randomisation
no blinding
no control group due to ethical reason
favorable outcomes observed imay be highly influenced by the strict protocol of daily monitoring and maintenance of the patients’ oral condition by the dental care team

"The findings of this study suggest a positive effect of an oral preventive care program for head and neck cancer patients submitted to RT. The PBMT associated with a rigorous POCP resulted in satisfactory control of oral adverse effects, reduction of quality of life impacts, and interruption of RT regimen due to severe OM."