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. 2023 Jan 19;15(3):532. doi: 10.3390/nu15030532

Table 2.

Clinical trials on breast cancer using intermittent fasting.

Clinical Trial Study Title Trial Phase Total Participants Status Primary Outcomes Details
NCT05023967 Metformin and Nightly Fasting in Women with Early Breast Cancer 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: 1 April 2022
Study completion: 30 November 2024
NCT05432856 [31] A randomized controlled trial of the effect of time restricted eating, healthy eating, and reduced sedentary behavior on metabolic health during chemotherapy for early-stage breast cancer NA 130 Not yet recruiting
  1. Visceral AT and regional AT pools.

  2. Metabolic syndrome severity.

  3. Cardiovascular risk estimate.

  4. Hemoglobin A1c and C-reactive protein.

  5. Chemotherapy symptom presence and severity.

  6. Safety.

Age: 18 years and older
Gender: female
Study start: January 2023
Study completion: December 2024
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: 15 June 2022
Study completion: 15 June 2023
NCT04691999 The Effect of Intermittent Fasting on Body Composition in Women With Breast Cancer NA 0 Withdrawn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: 2 December 2021
Study completion: August 2023
NCT04330339 Prolonged Nightly Fasting in Breast Cancer Survivors NA 40 Active, not recruiting 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: 24 July 2020
Study completion: 31 August 2021