Very low-carbohydrate ketogenic diet in treatment-naïve women with endometrial cancer and overweight: a randomized feasibility study

Cancer research · Endometrial cancer

We concluded that VLCD is feasible and well‑tolerated.

This multicenter, prospective, randomized controlled trial (NCT03285152) evaluates the primary endpoint of feasibility of a very-low carbohydrate diet (VLCD) in 19 women with obesity/overweight and endometrial cancer, who are randomized 2:1 to either a VLCD or a standard diet for 21‑28 days. Fifteen participants complete the study, with 91 ± 4% of VLCD meals consumed, 5.5 ± 0.8% weight lost, and no grade 3/4 adverse events. Secondary endpoints include assessments of tumor biology and circulating metabolic biomarkers. Fasting glucose and insulin fall 22 ± 5.9% and 60 ± 3.8%, while total cholesterol and low‑density lipoprotein (LDL) rise 6 ± 2.7% and 17.8 ± 8.9%. In a pre‑specified exploratory outcome, RNA‑Seq shows enrichment of CD8+ T‑cells (q < 0.034; NES > 1.75), confirmed by immunohistochemistry (IHC) showing CD8+ T‑cells infiltration of the tumor margins (q = 0.034; NES = 1.75). We conclude that VLCD is feasible and well‑tolerated.

This study demonstrates that a very‑low carbohydrate ketogenic diet is feasible, safe, and may enhance anti‑tumor immunity in treatment‑naïve women with endometrial cancer and obesity/overweight, highlighting a potential adjuvant nutritional strategy for this population.

Evidence level: Számítógépes vagy elméleti. Modellből vagy adatbányászatból származó jel.

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