145
Participants
Start Date
May 15, 2023
Primary Completion Date
May 15, 2025
Study Completion Date
May 15, 2026
Control diet (ARM A) or Fasting-Like Approach (FLA, ARM B)
Each FLA cycle will consist of 5 consecutive days of a specific FLA scheme, which will be repeated with a three-week interval. The FLA will consist of a plant-based, low-calorie (about 600 Kcal on day 1; about 300 Kcal on day 2 to 5), low-protein, low-carbohydrate diet. The first FLA cycle will start two days prior to the day of first chemo-immunotherapy cycle administration and will continue for two more days after chemotherapy. In the absence of significant contraindications or severe adverse events, subsequent FLA cycles will recur with three-week intervals and will maintain the same timing with respect to chemo-immunotherapy administration.
RECRUITING
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan
Collaborators (1)
Istituto Oncologico Veneto IRCCS
OTHER
Ospedale Policlinico San Martino
OTHER
Federico II University
OTHER
Azienda Policlinico Umberto I
OTHER
European Institute of Oncology
OTHER
"Ospedale Carlo Poma - Mantova"
OTHER
Humanitas Clinical and Research Center
OTHER
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
OTHER