Glioblastoma Clinical Trial
Official title:
Ketogenic Diets as an Adjuvant Therapy in Glioblastoma: A Randomised Pilot Trial
Glioblastoma (GB) is the commonest form of brain cancer in adults. Despite current treatment
options including surgery, radiotherapy and chemotherapy, overall survival 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 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 by comparing
two KDs in an NHS setting, with a view to informing future phase III clinical trials.
A prospective, non-blinded, randomized, pilot study will be undertaken in patients with
glioblastoma (GB). Patients will be randomized to the modified ketogenic diet (MKD) or the
medium chain triglyceride ketogenic diet (MCT) for a 12 week period (primary completion). If
patients wish to remain on diet, they will be offered dietetic support for a total of 12
months (secondary completion).
The trial will be open to all Walton Centre Foundation Trust patients with a newly diagnosed
GB, who have undergone surgical resection or biopsy within the last four months and who are
going on to receive/ are currently receiving/ have completed oncological treatments
(radiotherapy or chemotherapy or chemoradiotherapy). Patients will be referred via
neuro-oncology multi-disciplinary meetings and neurosurgical clinics, post histology. The
diet will be offered alongside standard care, commencing within four months of surgery.
Both diets are high in fat and low in carbohydrate, but contain different types and amounts
of fats. The MKD is 80% fat (predominately long chain fatty acids) and 5% carbohydrate,
whilst the MCT diet is 75% fat (30% of which is medium chain fatty acids) and 10%
carbohydrate.
A permuted block randomization method will be adopted, using 'sealedenvelope' randomization
system. This will be set up and administered by the statistician, who is not involved with
the recruiting of patients.
Patients will receive regular input from the trial dietitian. This includes clinical
consultations at baseline, dietary initiation, week 6, week 12 and every 3 months thereafter
and telephone consultations at weeks 1, 3 and 9. Patients will receive dietary and ketone
monitoring education.
Assessments and monitoring undertaken at each consultation include anthropometry,
biochemistry, compliance, tolerance, acceptability, quality of life and ketosis.
Informed consent will be obtained prior to enrollment and the patient may withdraw at any
time.
An information study is also embedded into KEATING, to aid understanding of the patients'
recruitment experience and viewpoints, by interviewing a sub-sample of patients and their
relatives/ carers. This will enable the design of bespoke strategies to optimise recruitment
to future trials related to ketogenic diets and gliomas
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