Table 1.

Water-only fasting and fasting-mimicking diets in clinical trials

	Type of study	Intervention	N=	Demographic	Type of malignancy	Other treatment	Outcome	Reference
Water-only fasting	Case series report	Fasting (48–140 h) prior to and/or following (5–56 h) CHX	10	7 female, 3 male; median age of 61 years (range 44–78 years)	Breast (4), prostate (2), ovarian, uterine, non-small cell lung carcinoma, and esophageal adenocarcinoma (1 each)	Docetaxel, cyclophosphamide, carboplatin, 5FU, carboplatin, paclitaxel, gemcitabine, doxorubicin	Reduction in chemotherapy-associated adverse events (CTCAE)	Safdie et al. 2009 [106]
	Randomized intervention (NCT01304251)	Fast 24 h before and after CHX	13	13 female; median age of 52 years (range 44–69 years)	HER2-negative, stage II/III breast cancer (13)	(Neo)-adjuvant docetaxel, doxorubicin, cyclophosphamide	Fasting was well tolerated and reduced hematological toxicity of CHX in HER2-negative BC patients; faster recovery of DNA damage in PBMCs	de Groot et al. 2015 [130]
	Randomized dose escalation (NCT00966364)	Fasting before CHX for 24, 48, and 72 h (divided as 48 pre-chemo and 24 post-chemo)	20	17 female, 3 male; median age of 61 years (range 31–75 years)	Urothelial (6), breast (5), non-small cell lung carcinoma (1), ovarian (6), uterine (2)	Gemcitabine, cisplatin, carboplatin, paclitaxel, trastuzumab	Safety and feasibility criteria met; reduced DNA damage in leukocytes from subjects who fasted for ≥ 48 h	Dorff et al. 2016 [129]
Fasting-mimicking diet	Randomized crossover (NCT02158897)	5-day FMD	100	63 female, 37 male; median age of 42 years	-	-	Safety and feasibility; reduced markers/risk factors for cancer	Wei et al. 2017 [33]
	Randomized crossover (NCT02158897)	< 400 kcal 36–48 h before and 24 h after the end CHX	34	34 female; median age of 51 years (range 28–69 years)	Breast (30), ovarian (4)	Docetaxel, paclitaxel, carboplatin, cyclophosphamide, epirubicin, doxorubicin, methotrexate, fluorouracil + IgG1 antibody bevacizumab, pertuzumab, or trastuzumab	Tolerability; improved quality of life and fatigue during CHX	Bauersfeld et al. 2018 [132]
	Randomized phase II (NCT03595540, NCT03340935)	5-day FMD	36	36 female; median age of 51 years (range 37–73 years)	Metastatic HR+ breast cancer (36).	Fulvestrant, palbociclib, exemestane, trastuzumab, pertuzumab, letrozole, GnRH agonist, abemaciclib, tamoxifen, everolimus	Tolerability; improved quality of life; partial clinical response	Caffa et al. 2020 [128]
	Multi-center, randomized phase II (NCT02126449)	4-day FMD (3 days prior to and on the day of CHX)	131	131 female; median age of 50 years (range 27–71 years)	HER2-negative stage II/III breast cancer (131)	Doxorubicin, cyclophosphamide, docetaxel, 5FU, epirubicin + dexamethasone	Radiologically complete or partial response, Miller and Payne 4/5 pathological response occurs more often in patients using the FMD	de Groot et al. 2020 [134]