Qin_2019

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

Qin

2019

Cancer Management and Research

pilot randomized study

N = 34

China, USA

01/2011 – 02/2012

prostate cancer

intensity-modulated radiotherapy (IMRT) or three-dimensional radiotherapy to the pelvis, seminal vesicles, and prostate with daily IGRT

Epinephrine group (n=16)

Median age: 68y

Control group (n=18)

Median age: 66.5y

N = 16

intra-rectal epinephrine (4 mg in 40 mL, n=16) 5 min before daily radiotherapy

N = 18

placebo (40 mL normal saline,

n=18) 5 min before daily radiotherapy

primary endpoint: feasibility and acute cardiovascular effects after intra-rectal infusion of epinephrine

secondary endpoint:

Assessment of radiation proctitis

No patient reported cardiovascular symptom side effects

No abnormal increase in blood pressure and/or

arrhythmia

5 weeks after the start of radiotherapy:

incidence of rectal toxicity ≥ grade 2: 27.8% (5/18) for the control group versus 12.5% (2/16) for the epinephrine group, (p=0.4).

no rectal toxicity ≥ grade 2 beyond 2-year follow-up.

epinephrine vs.  control group

5-year biochemical relapse-free survival: 75.0% vs. 72.2% respectively

The authors report no conflicts of interest in this work.

3

small sample size
no blinding
no information about concealment method

daily intrarectal infusion of epinephrine prior to radiotherapy
inconvenience to the patients
workload burden to the doctors, nurses, and therapists
enormous time and effort to keep patient compliance and protocol treatment compliance

"Results of this pilot randomized trial have demonstrated that intra-rectal administration of epinephrine is feasible and safe in prostatic radiotherapy. Its radioprotective effect warrants further investigation."