Background: A protective effect of the ketogenic diet (KD) on cancer cells has been indicated by in vivo and preclinical studies. It is suggested that the ketogenic diet confer protections through reducing cellular proliferation, tumor growth, inflammation, neovascularization, angiogenesis and an increased programmed cellular death via apoptosis. However there is no concrete evidence from high quality clinical trials that shows whether cancer patients would benefit from the ketogenic diet. Aim: we aim to investigate effects of a ketogenic diet in patients with breast cancer. Methods: we conduct a randomized clinical trial to investigate the effects of Medium-Chain Triglycerides (MCT) based KD on circulating biomarkers including lipid profiles, serum ketones, fasting blood sugar (FBS), insulin, insulin-like growth factor 1(IGF1), CEA, CA15-3, ESR, CRP, IL10, TNF alpha, LDH, liver and kidney marker, electrolyte, ammonia, albumin, TSH, T3, T4), pathological and biological features of tumor, body composition and quality of life. This study will be conducted in patients with locally advanced and metastatic breast cancer that will be referred to neoadjuvant chemotherapy in a medical oncology clinic. The intervention group (n=30) will undertake the KD for 3 months and patients in control group (30) will continue with their standard diet. Discussion: The findings of current study, which investigate the effectiveness of KD as an adjuvant or alternative therapy for cancer, will provide new insights into feasibility and safety of the KD as well as the potential mechanisms contributed in antitumor activity of this diet.
