TY - JOUR
T1 - Impact of Oocyte Extract Supplement on Quality of Life after Hepatectomy for Liver Tumours
T2 - A Prospective, Multicentre, Double-Blind Randomized Clinical Trial
AU - Donadon, Matteo
AU - Palmisano, Angela
AU - Bizzarri, Mariano
AU - Ceriani, Roberto
AU - Veneroni, Luigi
AU - Donati, Gabriele
AU - Tassinari, Davide
AU - Viola, Massimo Giuseppe
AU - Tamburini, Emiliano
AU - Torzilli, Guido
N1 - Publisher Copyright:
© 2023 by the authors.
PY - 2023/5
Y1 - 2023/5
N2 - Background: Previous studies on oocyte extract supplementation showed benefits in patients with liver tumours. In this trial, we hypothesized that the oocyte extract supplement impacted the QoL after hepatectomy for hepatocellular carcinoma and intrahepatic cholangiocarcinoma. Methods: This was a multicentre, double-blind, randomized clinical trial designed to assess the QoL of patients receiving a supplement of oocyte extract or placebo postoperatively. QoL was assessed using the Short Form-36 questionnaire in participants randomly assigned to treatment (Synchrolevels) or placebo. All study personnel and participants were masked to treatment assignment. The endpoint was the change in the QoL score. Results: Between June 2018 and September 2022, 66 of 128 expected patients were considered as per interim analysis, of which 33 were assigned to the treatment and 33 to the placebo group. Baseline and clinicopathological characteristics were similar between the two groups. In the treatment group, the health, mental and psychological status improved for many of the items considered, reaching statistical significance, while in the placebo group, those items either did not change or were impaired in comparison with the corresponding baseline. Conclusions: Supplementation with oocyte extract modifies QoL after liver surgery by enhancing functional recovery. Further in-depth studies are required to confirm this evidence.
AB - Background: Previous studies on oocyte extract supplementation showed benefits in patients with liver tumours. In this trial, we hypothesized that the oocyte extract supplement impacted the QoL after hepatectomy for hepatocellular carcinoma and intrahepatic cholangiocarcinoma. Methods: This was a multicentre, double-blind, randomized clinical trial designed to assess the QoL of patients receiving a supplement of oocyte extract or placebo postoperatively. QoL was assessed using the Short Form-36 questionnaire in participants randomly assigned to treatment (Synchrolevels) or placebo. All study personnel and participants were masked to treatment assignment. The endpoint was the change in the QoL score. Results: Between June 2018 and September 2022, 66 of 128 expected patients were considered as per interim analysis, of which 33 were assigned to the treatment and 33 to the placebo group. Baseline and clinicopathological characteristics were similar between the two groups. In the treatment group, the health, mental and psychological status improved for many of the items considered, reaching statistical significance, while in the placebo group, those items either did not change or were impaired in comparison with the corresponding baseline. Conclusions: Supplementation with oocyte extract modifies QoL after liver surgery by enhancing functional recovery. Further in-depth studies are required to confirm this evidence.
KW - cholangiocarcinoma
KW - hepatocellular carcinoma
KW - liver surgery
KW - oocyte extract
KW - postoperative recovery
KW - quality of life
KW - supplementation therapy in liver surgery
UR - https://www.scopus.com/pages/publications/85160611393
U2 - 10.3390/cancers15102809
DO - 10.3390/cancers15102809
M3 - Article
SN - 2072-6694
VL - 15
JO - Cancers
JF - Cancers
IS - 10
M1 - 2809
ER -