Fasting mimicking diet during neo-adjuvant chemotherapy in breast cancer patients: a randomized controlled trial study.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 39703333 · doi:10.3389/fnut.2024.1483707
What was done
Forty-four newly diagnosed HER2-negative breast cancer patients were randomized equally (22 per group) to receive either a fasting mimicking diet (FMD) or their regular diet for 3 days before and during neoadjuvant chemotherapy. This dietary protocol was repeated every 3 weeks for 8 cycles. Efficacy, toxicity, hematologic, metabolic, and inflammatory parameters were measured and compared between groups.
What was found
Grade III vomiting (p < 0.001) and grade III neutropenia (p = 0.04) occurred significantly more frequently in the control group than in the FMD group. After cycle 8, erythrocyte counts (p = 0.01) and neutrophil counts (p = 0.002) were significantly higher in the FMD arm. Between baseline and post-cycle 8, median glucose (p = 0.01) and median insulin (p = 0.005) increased significantly in controls, whereas median IGF-1 (p = 0.006) and hs-CRP (p = 0.02) decreased significantly in the FMD group. At study end, median glucose was higher in controls (p = 0.008) and median hs-CRP was lower in the FMD group (p = 0.01). Miller and Payne pathological response 4/5 (90–100% tumor cell loss) and radiologically complete or partial response occurred significantly more frequently in the FMD group (p = 0.01).
Why it matters
These findings suggest that a fasting mimicking diet can improve chemotherapy tolerance and augment pathological and radiological tumor response in HER2-negative breast cancer patients undergoing neoadjuvant treatment.
Limits
The study is limited by a small sample size (n = 44) from a single cohort of HER2-negative breast cancer patients. It lacks blinding inherent to dietary interventions, and long-term outcomes like recurrence-free and overall survival were not assessed.