Saadipoor_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

Saadipoor

2018

Phytotherapy Research

stratified, randomised, double‐blind, placebo‐controlled, parallel‐group study

single centre

Iran

03/2016 – 04/2017

patients with prostate cancer

3D conformal or intensity modulated radiotherapy (IMRT)

Placebo

n = 31

Age, Mean (SD), years: 71.5 (7.3)

% of rectum volume at 65 Gy, Mean % (SD): 16.6 (15.4)

% of bladder volume at 65 Gy, mean % (SD): 23.8 (13.1)

Nanocurcumin

n = 33

Age, Mean (SD), years: 69.0 (8.6)

% of rectum volume at 65 Gy, Mean % (SD):14.7 (7.2)

% of bladder volume at 65 Gy, mean % (SD): 28.8 (16.9)

n = 33

nanocurcumin (120 mg/day) 3 days before and during the RT course

n = 31

placebo 3 days before and during the RT course

primary endpoint: radiation‐induced proctitis

secondary outcomes: radiation‐induced cystitis, hematologic nadirs,

and treatment response

Placebo group vs.

Nanocurcumin

Acute toxicity, n (%)

Proctitis ≥ Grade I: 18 (58.1) vs. 15 (45.5); p=0.313

Proctitis ≥ Grade II: 3 (9.7) vs. 5 (15.2); P=0.709

Cystitis ≥ Grade I: 23 (74.2) vs. 29 (87.9); P=0.161

Cystitis ≥ Grade II: 8 (25.8) vs. 14 (42.4); P= 0.162

Duration of toxicity, mean weeks (SD)

Proctitis: 1.3 (1.4) vs. 1.2 (1.5); P=0.651

Cystitis: 2.5 (2) vs. 3.3 (1.6); P=0.309

Placebo group vs.

Nanocurcumin

Hematologic nadirs after adjustment for baseline values

Neutrophils: 2.89 (0.14) vs. 2.88 (0.13), 0.008 [−0.36, 0.38]; P=0.968

Lymphocytes: 1.01 (0.06) vs. 1.06 (0.05), 0.051 [−0.22, 0.11]; P=0.546

Platelets: 160.77 (5.77) vs. 159.59 (5.50), 1.180 [−14.79, 17.15]; P=0.883

Hemoglobin: 11.93 (0.13) vs. 11.77 (0.13), 0.159 [−218, 0.535]; P=0.403

mean tumor ADC increase

placebo: 228 (95% CI [63, 392]; p = 0.011)

nanocurcumin 269 (95% CI [149, 389]; p < 0.001)

The authors have declared that there is no conflict of interest.

2

single center
small number of pts
underpowered to accept or reject the study hypothesis

"In conclusion, this RCT was underpowered to indicate the efficacy of nanocurcumin in this clinical setting but could provide a considerable new translational insight to bridge the gap between the laboratory and clinical practice."