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. 2022 Aug 10;113(10):3291–3302. doi: 10.1111/cas.15492

TABLE 2.

Clinical trials of cancer using intermittent fasting

Clinical trial Study title Trial phase/total participants Status Primary outcome measure Remarks
NCT05023967 Metformin and Nightly Fasting in Women with Early Breast Cancer Phase 2/120 Not yet recruiting

  1. Change in pre‐post treatment Ki67 labeling index in invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS) (in the absence of IBC)

  2. Difference in post‐treatment adjacent DCIS (in the presence of IBC), if present, or intraepithelial neoplasia Ki67 between arms

  3. Frequency of occurrence of dose‐limiting toxicity

Age: 18 years and older

Gender: Female

Study start: April 1, 2022

Study completion: November 30, 2024
NCT04626843 Intermittent Fasting and CLL/SLL Phase 1/20 Recruiting

  1. Change in lymphocyte, quality of life, inflammation, metabolic profiles, autophagy status

  2. Immune cell gene expression profiles

Age: 19–85 years

Gender: All

Study start: February 3, 2021

Study completion: December 2021
NCT04560439 Diabetes Prevention Program (METFIT) in Reducing Insulin Resistance in Stage I‐III Breast Cancer Survivors NA/25 Recruiting

  1. Fidelity

  2. Retention

  3. Change in insulin resistance (IR)

Age: 18–75 years

Gender: Female

Study start: June 15, 2022

Study completion: June 15, 2023
NCT02710721 Fasting and Nutritional Therapy in Patients with Advanced Metastatic Prostate Cancer NA/60 Active, not recruiting

  1. FACT‐P/‐Taxane/−A sum score

  2. HADS

Age: 25–89 years

Gender: Male

Study start: April 2016

Study completion: December 2021
NCT05114798 Time‐restricted Eating Versus Daily Continuous Calorie Restriction on Body Weight and Colorectal Cancer Risk Markers NA/255 Not yet recruiting

  1. Weight change (% kg)

Age: 25–89 years

Gender: All

Study start: April 2022

Study completion: September 2026
NCT03523377 Overnight Fasting After Completion of Therapy: The OnFACT Study NA/40 Recruiting

  1. Participation completion measure of glucose metabolism

Age: 18 years and older Years

Gender: All

Study start: April 27, 2018

Study completion: April 2024
NCT04387084 Short‐term Fasting Prior to PD‐1/PD‐L1 Inhibitor Therapy for of Advanced or Metastatic Skin malignancy Phase 1 /16 Recruiting

  1. Percentage of patients completely adhering to three cycles of short‐term fasting (STF) (9 days of fasting)

  2. Percentage of patients who develop unacceptable fasting‐related toxicity

  3. Percentage of patients who can partially adhere to three cycles of STF (9 days of fasting)

  4. Incidence of acceptable fasting related toxicity

Age: 18 years and older

Gender: All

Study start: August 12, 2020

Study Completion: August 12, 2023
NCT02286167 Glioma Modified Atkins‐based Diet in Patients with Glioblastoma NA/25 Completed

  1. Feasibility of intermittent modified Atkins diet in patients with GBM assessed by percent of patients able to remain on a diet and achieve nutritional goals

  2. Biologic activity measured by pre‐and post‐study cerebral glutamate and glutamine concentrations assessed by MRS.

  3. Tolerability assessed by percent of patients who have an adverse reaction of any grade attributed to the diet of possible, probable, or definite

  4. Dietary activity

Age: 18 years and older

Gender: All

Study start: November 2014

Study completion: July 12, 2019
NCT03151161 Intermittent and Maintenance of Icotinib in Combination with Pemetrexed/Carboplatin Compared With Icotinib Single Drug in IIIb/IV Non‐Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation Phase 2/118 Unknown Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Age: 18–75 years

Gender: All

Study Start: December 2015

Study completion: May 2019
NCT02066038 Intermittent and Maintenance of Erlotinib in Combination With Pemetrexed/Carboplatin in IIIb/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation Phase 2/60 Unknown Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Age: 18–75 years

Gender: All

Study Start: January 2014

Study completion: March 2016
NCT04691999 The Effect of Intermittent Fasting on Body Composition in Women With Breast Cancer NA/0 Withdrawn

  1. Adherence to the intermittent fasting program

  2. Change in body fat

Age: 20–70 years

Gender: Female

Study start: December 2, 2021

Study completion: August 2023
NCT04288336 Daily, Long‐Term Intermittent Fasting for the Prevention of PSA‐Recurrence in Patients with Localized Prostate Cancer After Radical Prostatectomy Early Phase 1/25 Recruiting

  1. Adherence to the daily intermittent fasting regimen

  2. Prostate specific antigen (PSA) kinetics and/or doubling time

Age: 18 years and older

Gender: Male

Study start: January 8, 2020

Study completion: June 1, 2022
NCT03162289 Intermittent Fasting Accompanying Chemotherapy in Gynecological Cancers NA/150 Recruiting

  1. FACT‐G

  2. Complete remissions

  3. Millar Payne classification

Age: 18–75 years

Gender: Female

Study start: May 10, 2017

Study completion: June 10, 2022
NCT05083416 Effect of Prolonged Nightly Fasting on Immunotherapy Outcomes in HNSCC ‐ Role of Gut Microbiome NA/52 Recruiting

  1. Rates of prolonged nightly fasting (PNF) compliance

  2. Change in gut microbiome and microbial metabolites

Age: 18 years and older

Gender: All

Study start: September 28, 2021

Study completion: August 2022
NCT04708860 Feasibility of Fasting & Exercise in Pts With HR+ MBC NA/30 Recruiting
  1. Rate of enrollment
  2. Rate of adherence to prolonged overnight fasting (POF) intervention goals
  3. Rate of adherence to exercise intervention goals

Age: 18 years and older

Gender: Female

Study start: January 15, 2021

Study completion: July 31, 2023
NCT04557540 Weight Loss Interventions for Black Adults of Faith NA/60 Recruiting
  • 4
    Obesity‐related malignant neoplasm
  • 5
    Change in body weight, body composition, height, heart rate, blood pressure, waist circumference, hip circumference

Age: 18 years and older

Gender: All

Study start: August 25, 2020

Study completion: September 15, 2023
NCT04330339 Prolonged Nightly Fasting in Breast Cancer Survivors NA/40 Active, not recruiting

  1. Baseline assessment (measurements of weight, height, quality of life, fatigue, mood, levels of physical activity, and blood markers) prior to the intervention and after completion of 12 week intervention

Age: 18 years and older

Gender: female

Study start: July 24,2020

Study completion: August 31, 2021
NCT04345978 Effects of Fasting Strategies on Postoperative Recovery and Long‐term Prognosis in Patients with Colorectal Cancer NA/2400 Active, not recruiting

  1. Disease free survival

Age: 20–70 years

Gender: All

Study start: January 1,2020

Study completion: September 30,2023
NCT04461938 Characterization of Metabolic Changes in the Glioma Tumor Tissue Induced by Transient Fasting (ERGO3) NA/15 Recruiting

  1. Changes in metabolism‐induction of ketosis

  2. General metabolic change

  3. Immunological change

  4. Alterations in electric brain activity

Age: 18 years and older

Gender: All

Study start: August 19, 2020

Study completion: March 2022
NCT03700437 Fasting‐mimicking Diet With Chemo‐immunotherapy in Non‐small Cell Lung Cancer (NSCLC) NA/10 Recruiting

  1. Proportion of the patients who can finish the FMD without serious adverse events

Age: 18–70 years

Gender: All

Study start: November 2, 2018

Study completion: December 2024