e12522 Background: Fasting may help reduce the toxicity of certain chemotherapy drugs but a low calorie, low protein fasting-mimicking diet (FMD) may be more feasible than prolonged fasting. We evaluated whether the FMD will reduce chemotherapy toxicity when used with neoadjuvant or adjuvant chemotherapy in breast cancer (BC) or docetaxel chemotherapy in prostate cancer (PC). Methods: Patients were randomized (1:1) to FMD (arm A) consumed 3 days prior to and 24 hours after chemotherapy for 4 cycles, or regular diet (Arm B). Eligibility: BMI > 18.5. Exclusion: Insulin treated Diabetes Mellitus. Results: 121 subjects were accrued, PC, n = 25, BC n = 96. 99 subjects received 3 or more cycles of chemotherapy. 39 of 59 subjects in FMD arm, 66% completed 3 or more cycles of the FMD, whereas 47% were compliant with 4+ cycles. 7 BC and 1 PC patients in Arm A did not submit any FMD records, so, these 8 (14%) patients were counted among those who did not use the FMD. Rate of NHST during the first four chemotherapy cycles was 39% in Arm A compared to 35% in Arm B (p = 0.35), however grade 3+ NHST was 3% in in the FMD Arm (A) compared to 10% in Arm B (p = 0.08). Grade 2+ hematologic toxicity occurred in 5% of patients in FMD Arm (A) and 10% in Arm B (p = 0.17) and grade ≥3 hematologic toxicity observed in 3% in FMD Arm versus 6% in the control Arm (p = 0.22). Grade ≥2 nausea occurred in 7% of patients in FMD Arm (A) compared with 3% in Arm B (p = 0.19), while no grade ≥2 vomiting was reported in FMD Arm (A) compared with 2% in Arm B (p = 0.17). FMD-related toxicity among BC patients included grade 2+ nausea in 6%, with no grade 3–4 events; the highest grade 2+ toxicity was fatigue (9%). Among PC patients, grade ≥2 nausea was not observed; grade 3+ toxicities included fatigue (8%) and pain in extremity (8%), and one patient experienced grade 3 memory impairment (8%). In FMD Arm A, 10% of patients required chemotherapy dose reduction or hold compared to 3% in Arm B. Changes in QOL could not be determined due to missing data. Conclusions: FMD was safe and feasible in patients receiving chemotherapy for both breast and prostate cancer, although accrual was limited in the PC cohort. While the primary toxicity endpoint was not met, grade ≥3 toxicities were lower in patients receiving the FMD. Heterogeneity of chemotherapy regimens and incomplete accrual limited power to detect the prespecified difference. Analyses of compliance and the proportion of chemotherapy cycles completed with FMD may help inform future studies. Clinical trial information: NCT01802346 .
Shelechi et al. (Thu,) studied this question.