A randomized phase II clinical trial of a fasting-mimic diet prior to chemotherapy to evaluate the impact on toxicity and efficacy.

TPS10132Background: Chemotherapy toxicity impacts dose intensity as well as temporarily deteriorating quality of life; some toxicity can be permanent, such as neuropathy. We previously demonstrated that fasting induces Differential Stress Resistance and hypothesized that fasting may protect normal host cells from chemotherapy toxicity, while potentially sensitizing cancer cells to chemotherapy. A low calorie, low protein fasting-mimicking diet (FMD) may be more acceptable than pure fasting. We are studying whether FMD will reduce chemotherapy toxicity and/or enhance efficacy. Changes in glucose and insulin‐like growth factor 1 (IGF1) may mediate or be biomarkers for the protective effects of fasting and will be studied in the trial population. Methods: Randomized phase II in 2 parallel cohorts (Prostate, n = 60, Breast n = 60). Treatment: Arm A = restricted diet consumed 3 days prior to and 24 hours after chemotherapy for 4 cycles. Arm B = regular diet. Eligibility: breast cancer with AC or TC in neoadjuv...