The KEATING trial
Research type
Research Study
Full title
Ketogenic diets as an Adjuvant Therapy In Glioblastoma: A Randomised Pilot Study
IRAS ID
218922
Contact name
Michael D Jenkinson
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
1 years, 11 months, 28 days
Research summary
Glioblastoma (GB) is the commonest form of brain cancer in adults. Despite current treatment options including surgery, radiotherapy and chemotherapy, overall survival for these patients is poor. Therefore, other treatment options are being explored and there is increasing interest in the possibility of using the ketogenic diet (KD), alongside current treatment options.
The KD is a high fat, low carbohydrate diet. This encourages the body to use fat (broken down to ketones) as its primary energy source, instead of carbohydrate (broken down to glucose, a type of sugar). KDs have been considered for use in patients with GB as this type of cancer is thought to use glucose as its main energy supply, which is of short supply in this diet. Animal studies have shown KDs may make GB more responsive to radiotherapy and chemotherapy and could improve survival by slowing the cancer’s growth. However, clinical studies are needed in humans to assess any possible benefits.
This trial will see patients randomly assigned to one of two types of KDs; the modified ketogenic diet (MKD) and the medium chain triglyceride ketogenic diet (MCT). Both diets follow the same high fat, low carbohydrate principles, with the MCT diet requiring the patient to take some of the fat as a supplement drink instead of as a food. Patients will follow the diet for 12 weeks initially. The trial will look to enroll newly diagnosed GB patients, from the Walton Centre NHS Foundation Trust over a 12 month period.
The aim of the trial is to investigate protocol feasibility and patient impact (factors such as quality of life, food acceptability, weight changes, gastrointestinal side effects) by comparing two KDs in an NHS setting, with a view to informing future phase III clinical trials.
The study is funded by Vitaflo International Ltd.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
17/NW/0013
Date of REC Opinion
13 Jan 2017
REC opinion
Favourable Opinion