A phase 1 safety and feasibility trial of a ketogenic diet plus standard of care for patients with recently diagnosed glioblastoma.

ABSTRACT: Despite great interest, there is limited clinical evidence to support the use of a ketogenic diet (KD) for cancer patients. We conducted a single-arm phase 1 trial of a KD among patients with recently diagnosed glioblastoma (GBM) receiving standard-of-care (SOC) treatment. Adults with GBM within 3 months of diagnosis followed a supervised 16-week intervention of a 3:1 KD (Fat(g): Carbohydrate + Protein(g)) plus SOC chemoradiation. The primary outcome was safety, evaluated by weekly assessments of weight and body mass index (BMI). Secondary outcomes included feasibility (pre-specified as > 50% of patients maintaining blood ketone levels > 0.3 mM over 50% of study days), progression-free survival (PFS), overall survival (OS), health-related quality-of-life, and cognitive function. Twice dail

SUBMITTER: Amaral LJ 

PROVIDER: S-EPMC12215994 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature