Short-term Fasting Compared to Free Diet on Ovarian Cancer Patients

The primary endpoint of the study is the reduction of insulin levels between the two groups. Using the Student's t-test, while maintaining the study power at 95% and the significance level at 5%, a sample of 27+27 patients will allow the identification of differences in terms of Cohen's d equal to 1.

The aim of this study is to investigate the effect of STF on OC patients, receiving NACT. The impact on metabolic and endocrine parameters will be investigated, including Insulin level, in order to correlate IGF-1 values and clinical response rate. In particular, the study aims at investigating the reduction in mean insulin levels among different groups (primary endpoint); the effects of the different dietary regimens on metabolic, endocrine, haematologic, inflammatory and tumoral marker response to NACT, the impact of STF on body weight and body composition, ORR, tolerability and toxicity grade experienced by each patient, PFS, QoL and OS will be investigated as secondary clinical outcomes. As translational endpoints, the study will assess the ability of different dietary regimens to modify the immune system; also, the influence of gut microbiota on the chemotherapeutic regimen and on the immune system status in correlation with dietary approach will be explored. Finally, the correlation of intestinal resection during IDS and thereafter the modulation of gut microbiota will be investigated