The ketogenic diet for patients with brain tumours: Two parallel randomised trials

Abstract

The ketogenic diet (KD) has attracted considerable interest from the brain tumour community. There is evidence for synergy with radiotherapy in animal models, and improved seizure control in children with epilepsy due to structural abnormalities. However, there is little data on mechanism or effect in brain tumour patients, and different options for implementing the ketogenic diet. In November 2016 we assembled multiple stakeholders, including the James Lind PSP in neuro‐oncology and several charities to develop a trial outline. We addressed mechanistic, clinical and practical factors to develop a trial protocol. Based on the meeting, we are planning two parallel open‐label phase 2 randomised trials of the Modified Ketogenic Diet (MKD) in patients with high grade gliomas (HGG) receiving chemoradiotherapy, and in patients with low‐ grade gliomas (LGG). Patients will be enrolled following a histological diagnosis and informed consent. They will receive training on a Modified Ketogenic Diet (MKD) and dietetic support throughout the trial. Patients will be aged 18+, performance score