Table 1.

Ongoing clinical trials employing FMDs in cancer patients.

Clinicaltrials.gov registration number	Title of the registered study	Status	Study design	Primary endpoint	Clinical setting	n	Type and schedule of FMD regimen	Study sponsor
NCT04292041	Fasting Mimicking Diet in Prostate Cancer and Metabolic Syndrome, a Pilot Study	Active, not recruiting	Prospective, single-arm trial	Change in baseline weight, blood pressure, waist circumference, triglycerides, Total, LDL, and HDL Cholesterol at 6 months	Prostate cancer patients with metabolic syndrome receiving standard treatment options	40	Chemolieve® for 3 cycles	Galway Clinic, Galway, Ireland
NCT03340935	Safety, Feasibility and Metabolic Effects of the Fasting Mimicking Diet (FMD) in Cancer Patients	Recruiting	Monocentric, single-arm, phase I/II trial	Safety of FMD, as defined as incidence of severe, FMD-related adverse events	Malignant neoplasms	95	5-day plant-based, low-calorie (600 Kcal on day 1, followed by 300 KCal/day on days 2–5), low-protein, low-carbohydrate diet composed of fresh food concomitantly with standard antitumor therapies	Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
NCT03595540	Phase II Clinical Study of a Fasting-Mimicking Diet in Patients Undergoing Oncologic Treatment	Recruiting	Monocentric, single arm, phase I/II trial	Feasibility and safety of FMD	Solid or hematologic tumors undergoing active treatment	60	Prolon by L-Nutra concomitantly with standard antitumor therapies	University of Genova, Italy
NCT03700437	Randomized Controlled Pilot Study to Evaluate Fasting-mimicking Diet in Patients Receiving Chemo-immunotherapy for Treatment of Metastatic Non-small Cell Lung Cancer	Recruiting	Open Label, Randomized, phase II controlled trial	-Changes in CTCs -DNA damage in CTCs -PBMC profiles	Stage IV Lung Adenocarcinoma for which combined chemo- immunotherapy in the form of carboplatin/pemetrexed and pembrolizumab is being utilized.	40	Chemolieve® for 3 days prior to and on the day of chemo-immunotherapy during the first 4 cycles	Indiana University, USA
NCT03709147	Exploiting Metformin Plus/Minus Cyclic FAsting Mimicking Diet (FMD) to Improve the Efficacy of Platinum-pemetrexed Chemotherapy in Advanced LKB1-inactive Lung Adenocarcinoma: the FAME Trial	Not yet recruiting	Single Institution, open-label, double arm, non-comparative, randomized, single-stage phase II trial, with “pick-the-winner” design	Progression-free survival	Stage IV LKB1- inactive Lung Adenocarcinoma	88	5-day plant-based, low-calorie (600 Kcal on day 1, followed by 300 KCal/day on days 2–5), low-protein, low-carbohydrate diet composed of fresh food concomitantly with standard antitumor therapies, to be repeated every 3 weeks up to a maximum of 4 cycles	Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
NCT03454282	Impact of Dietary Intervention on Tumor Immunity: the DigesT Trial	Recruiting	Monocentric, single-arm with three cohorts of patients	Absolute and relative changes in PBMCs	-Invasive breast cancer candidate to upfront curative surgery (Cohort A) -resected stage III melanoma (Cohort B) -resected, stage IIB/IIC melanoma (Cohort C)	100	5-day plant-based, low-calorie (600 Kcal on day 1, followed by 300 KCal/day on days 2–5), low-protein, low-carbohydrate diet composed of fresh food concomitantly with standard antitumor therapies	Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
NCT04248998	Targeting Triple Negative BREAst Cancer Metabolism With a Combination of Chemotherapy and a Diet Mimicking FASTingPlus/Minus Metformin in the Preoperative Setting: the BREAKFAST Trial	Recruiting	Single center, open-label, double arm, randomized, single stage, phase II trial	pCR rate	Triple Negative Breast Cancer candidate to neoadjuvant chemotherapy	90	5-day plant-based, low-calorie (600 Kcal on day 1, followed by 300 KCal/day on days 2–5), low-protein, low-carbohydrate diet composed of fresh food concomitantly with standard antitumor therapies	Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
NCT04027478	Can Fasting Decrease the Side Effects of Chemotherapy?	Enrolling by invitation	Open label, prospective randomized crossover trial.	Incidence of grade II/III/IV nausea	Patients undergoing chemotherapy with Taxol/carboplatin planned for at least 6 cycles	39	FMD consisting of 10 Kcal/kg/day and including 50% fat, 40% carbohydrates, and no more than 10% protein. The diet includes nuts, olives, vegetable broth, broccoli/cauliflower, white rice/puffed rice cake, onion, tea/coffee, almond milk. The diet prohibits meat products, dairy, alcohol, sugar, and artificial sweeteners.	Sutter Cancer Center, Sacramento, California, United States
NCT02710721	Clinical Study on the Efficacy of Fasting and Nutritional Therapy as a Complementary Treatment of Advanced Metastatic Prostate Cancer Undergoing Chemotherapy—an Exploratory Randomized Controlled Trial	Recruiting	Open Label, Randomized trial	FACT-P/-Taxane/-An sum score	Castration-resistant prostate cancer or hormone-sensitive metastatic prostate cancer with high disease burden	60	A 60 h-modified fasting (36 h before and 24 h after chemotherapy) with a dietary energy supply 350–400 kcal per day with fruit and vegetable juices or, if not feasible, an established FMD of 600-800 kcal (Chemolieve®)	Charité Centrum Chirurgische Medizin, CC 8 Klinik für Urologie, Berlin, Germany

Chemolieve® is a 4-day plant based low amino-acid substitution dietary kit, consisting of soups, broths, liquids, and tea

Prolon by L-Nutra is a 5-day dietary kit. Day 1 of Prolon provides ~4600 kJ (11% protein, 46% fat, and 43% carbohydrate), whereas days 2-to-5 provide ~3000 kJ (9% protein, 44% fat, and 47% carbohydrate) per day.

CTC, circulating tumor cells; FACT-P, functional assessment of cancer therapy-prostate cancer; FMD, fasting-mimicking diet; pCR, pathologic complete response; PBMC, peripheral blood mononuclear cells.