MKD: 80% fat and 5% carbohydrate (% of total energy requirements per day).

MCT: 75% fat (30% of which is medium chain fatty acids taken as a supplement) and 5% carbohydrate (% of total energy requirements per day).

Glioblastoma

Glioblastoma Multiforme

Glioblastoma, Adult

Univeristy of Liverpool/ The Walton Centre NHS Foundation Trust

Ketogenic Diets as an Adjuvant Therapy in Glioblastoma

Ketogenic Diets as an Adjuvant Therapy in Glioblastoma: A Randomised Pilot Trial

Number of patients who start randomized treatment as a proportion of the number randomized ;

The number of patients who complete 12 weeks as a proportion of the number randomized

Description of barriers and facilitators to data collection and participant retention

Actual recruitment compared to proposed recruitment

Number of patients initiated on diet prior to starting oncological treatments.

Number of patients initiated on diet during oncological treatments.

Number of patients initiated on diet post oncological treatments.

Time to dietary discontinuation after week 12

Number of dietary adjustments to macronutrient composition of MCT and MKD diets required to achieve ketosis.

Analysed by comparing macronutrient content assessed via 3 day food diaries to advised macronutrient content.

Dose of MCT taken compared to dose advised.

Self reported urinary ketone levels twice daily for first 6 weeks then once per week thereafter and blood ketone and glucose levels weekly.

Dietetic time spent on clinical and non clinical activities relating to the trial.

Number of deviations from the protocol including reasons for deviations.

Number of participants required for future phase III clinical trials

Change in quality of life assessed through EORTC QLQ C30 and BN 20 questionnaires

Change in food acceptability assessed through food acceptability questionnaire

Number of reported gastrointestinal side effects assessed through EORTC QLQ C30 questionnaire and Common Terminology Criteria for Adverse Events.

Changes to biochemical markers (renal, bone, LFT, lipid profiles) during the duration of the diet.

Changes to anthropometry (weight, body mass index, fat mass, muscle circumference, hand grip strength) during the duration of the diet.

Number of complete data sets for all trial outcomes

Michael Jenkinson

Chief Investigator

University of Liverpool

Walton Centre NHS Foundation Trust

Vitaflo International, Ltd

Treatment will consist of ketogenic diet. KD will consist of 4:1 [fat] : [protein+carbohydrate] weight ratio with 1600 kcal restriction. The diet will be supplemented with vitamins, calcium, phosphorus, zinc and selenium supplements to meet the requirements of US Dietary Reference Intakes (DRI) standard.

ketogenic diet

MidAtlantic Epilepsy and Sleep Center

Ketogenic Diet as Adjunctive Treatment in Refractory/End-stage Glioblastoma Multiforme: a Pilot Study

Early treatment discontinuation, treatment compliance, 7-point Licker hunger scale, fasting lipid levels and fasting serum glucose and insulin levels

The secondary outcome measures will be (i) survival time and (ii) time to cerebral edema requiring steroid rescue treatment

glioblastoma/triglyceride

Ketogenic Diets as an Adjuvant Therapy in Glioblastoma

Ketogenic Diet as Adjunctive Treatment in Refractory/End-stage Glioblastoma Multiforme: a Pilot Study

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