Reduced Carbohydrates In Resistant Aggressive Tumors, The Recharge Trial: A Safety And Feasibility Nutritional Study In Ten Patients

Background: Many aggressive cancers share a glycolytic phenotype associated with increased 18F-2-fluoro, 2-deoxyglucose (FDG) positron emission tomography (PET) uptake. Carbohydrate restricted (CR) diets, by inhibiting insulin secretion, enlist plausible but unproven mechanisms to limit cancer growth. Objectives: We evaluated safety/feasibility of a CR diet in patients with advanced FDG-avid cancers using a change in exit vs. baseline FDG uptake as a surrogate measure of tumor response using prospective EORTC criteria. Methods: Patients with advanced, incurable cancers and FDG-positive scans were recruited. Eligibility required ECOG performance status of 0-2, normal hepatic, renal, and gastrointestinal function, no diabetes or recent weight loss (> 5% within 3 months), and a body mass index of >20 kg/M2. A supervised CR diet (5% of total kCal) was monitored weekly for macronutrient intake, body weight, serum electrolytes, betahydroxybutyrate concentrations [BHB]. An exit four-week PET scan was obtained. Results: Ten subjects with advanced cancer completed > 26 days of the diet without associated adverse effects. Mean daily caloric intake decreased (35 + 6) % vs. Harris-Benedict formula9s predicted energy requirements, and median/mean weight loss were 4.1% (range 0.0-6.1%.) and (4.1 + 0.7) %, respectively. One patient had advanced but indolent disease (14 years without chemotherapy). Among nine patients with pre-trial progressive disease (Table 1), 4 continued to progress on PET, and 5 did not. Non-progression (n=5) vs. continued progession (n=4) correlated (p=0.02) with three fold higher dietary ketosis but not with reduced energy intake (p=0.65). Conclusions: Preliminary data suggest safety/feasibility of carbohydrate restriction in patients with advanced cancer, and that ketosis correlated with disease stabilization, supporting further evaluation of CR as a complementary approach in conjunction with standard therapies. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 102nd Annual Meeting of the American Association for Cancer Research; 2011 Apr 2-6; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2011;71(8 Suppl):Abstract nr 4083. doi:10.1158/1538-7445.AM2011-4083