Table 1 Ongoing clinical trials employing FMDs in cancer patients.

From: Fasting-mimicking diet plus chemotherapy in breast cancer treatment

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
  1. Chemolieve® is a 4-day plant based low amino-acid substitution dietary kit, consisting of soups, broths, liquids, and tea
  2. 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.
  3. 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.