Impact of Oocyte Extract Supplement on Quality of Life after Hepatectomy for Liver Tumours: A Prospective, Multicentre, Double-Blind Randomized Clinical Trial

SIMPLE SUMMARY: Quality of life (QoL) is an important and modifiable concept that should be taken into considerations during treatment allocation in cancer patients. In the last 15 years, studies have reported that supplementation with oocyte extract, which is pivotal during the stage of cell differentiation, may be associated with reduction or suppression of tumour growth and may be, in fact, beneficial in patients with liver tumours. Here, we designed a multicentre, double-blind, randomized clinical trial to assess whether the QoL of patients operated for liver tumours was impacted by receiving a supplement of oocyte extract postoperatively. As shown, the supplement of oocyte extract modifies the QoL after liver surgery by enhancing the functional recovery for many of the QoL items considered. The same result was not recorded with the placebo. ABSTRACT: 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.