Ketogenic Diets as an Adjuvant Therapy in Glioblastoma

NCT03075514 | Completed

• 1 other identifier: UoL001277
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastoma; Glioblastoma Multiforme; Glioblastoma, Adult

Keywords

ketogenic

Outcome Measures

Primary Outcomes (4)

• To assess retention and drop out rates

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

  12 weeks

• To assess retention and drop out rates

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

  12 weeks

• To assess retention and drop out rates

  Description of barriers and facilitators to data collection and participant retention

  12 weeks

• To assess retention and drop out rates

  The time to dietary discontinuation

  12 weeks

Secondary Outcomes (19)

• Estimation of recruitment rates

  12 months

• Enrollment of patients

  12 months

• Enrollment of patients

  12 months

• Enrollment of patients

  12 months

• Long term retention

  2 years

Study Arms (2)

Modified ketogenic diet (MKD)

ACTIVE COMPARATOR

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

Other: MKD

Medium chain triglyceride (MCT) diet

ACTIVE COMPARATOR

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

Other: MCT

Interventions

MKD OTHER

Modified ketogenic diet

Modified ketogenic diet (MKD)

MCT OTHER

Medium chain triglyceride ketogenic diet

Medium chain triglyceride (MCT) diet

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥16 years
• Patient at The Walton Centre NHS Foundation Trust
• Performance status ≤2
• Confirmed histological diagnosis of glioblastoma
• Undergone surgical resection or biopsy and will go onto receive/ is receiving/ has received oncological treatments

You may not qualify if:

• Having prior use of KD
• Kidney dysfunction
• Liver dysfunction
• Gall bladder dysfunction
• Metabolic disorder
• Eating disorder
• Diabetes (requiring medication)
• Body mass index ≤ 18.5kg/m2
• Weight loss medications
• Currently pregnant or breast feeding
• Performance status ≥3

Sponsors & Collaborators

• University of Liverpool: lead
• Walton Centre NHS Foundation Trust: collaborator
• Vitaflo International, Ltd: collaborator

Study Sites (1)

Univeristy of Liverpool/ The Walton Centre NHS Foundation Trust

Liverpool, Merseyside, L9 7LJ, United Kingdom

Location

Related Publications (1)

• Martin-McGill KJ, Marson AG, Tudur Smith C, Jenkinson MD. Ketogenic diets as an adjuvant therapy in glioblastoma (the KEATING trial): study protocol for a randomised pilot study. Pilot Feasibility Stud. 2017 Nov 28;3:67. doi: 10.1186/s40814-017-0209-9. eCollection 2017.

  PMID: 29209515 DERIVED

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Michael D Jenkinson, PhD, FRCS

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Model Details: MKD and MCT ketogenic diets

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 9, 2017
• Study Start: April 1, 2017
• Primary Completion: March 5, 2019
• Study Completion: March 5, 2019
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)