Brief Report: A Pilot Study Evaluating the Feasibility, Safety, and Compliance With a Fasting-Mimicking Diet in
Fatima Ghaddar1, Shahid Ahmed1, Beth Kirsch1
1Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN.
Introduction:
The fasting-mimicking diet (FMD) is a plant-based, calorie-restricted, low-carbohydrate, low-protein, 4- or 5-day diet that reproduces short-term fasting physiology and promotes synergy with cancer therapies. Despite established safety and feasibility, FMD data in advanced lung cancer remain lacking.
Materials And Methods:
This open-label, single-arm, single-center pilot study recruited metastatic non-small cell lung cancer (NSCLC) adult patients (Body mass index >18, Eastern Cooperative Oncology Group performance status [PS] 0-2) who were clinically stable on first-line therapy for ≥2 months. Patients received one 4-day FMD. Primary outcomes were feasibility (proportion completing FMD), safety (proportion completing FMD without grade 3-4 adverse events), and compliance with FMD caloric requirements. Weight and biologic measures-complete blood counts and metabolic panels-were obtained at baseline and 21 or 28 days post-FMD. Weight was also measured during FMD. The secondary outcome was self-reported willingness to repeat FMD.
Results:
Ten participants initiated FMD. Median age was 57.2 years (40.5, 76.2), median baseline Body mass index 28.1 (22.6, 37.5), and baseline Eastern Cooperative Oncology Group PS 0-1. Most patients were female (70%), had adenocarcinoma (90%), and received oral targeted therapy (80%). Fifty percent were White/Caucasian, 30% Black/African American, and 20% Asian. Ninety percent completed FMD. No grade 3 to 4 adverse events occurred. Most common side effects were grades 1 to 2-nausea (30%), abdominal pain (20%), fatigue (20%), headache (20%). Weight loss remained < 10% from baseline. Biologic markers were normal. Compliance rate was 70% (95% CI, 34.8-93.3). Eighty percent of patients expressed willingness to repeat FMD.
Conclusion:
A single FMD cycle is safe and feasible in relatively young, advanced NSCLC patients on oral targeted therapy.
Clinical Trial Information:
ClinicalTrials.gov Identifier: NCT03700437.
