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Randomized Controlled Trial
. 2020 Mar;147(1):213-227.
doi: 10.1007/s11060-020-03417-8. Epub 2020 Feb 8.

Ketogenic diets as an adjuvant therapy for glioblastoma (KEATING): a randomized, mixed methods, feasibility study

Kirsty J Martin-McGill  1   2 , Anthony G Marson  3   4 , Catrin Tudur Smith  5 , Bridget Young  6 , Samantha J Mills  4 , M Gemma Cherry  7   8 , Michael D Jenkinson  3   4
Affiliations
Randomized Controlled Trial

Ketogenic diets as an adjuvant therapy for glioblastoma (KEATING): a randomized, mixed methods, feasibility study

Kirsty J Martin-McGill et al. J Neurooncol. 2020 Mar.

Abstract

Purpose: We conducted a feasibility study to investigate the use of ketogenic diets (KDs) as an adjuvant therapy for patients with glioblastoma (GBM), investigating (i) trial feasibility; (ii) potential impacts of the trial on patients' quality of life and health; (iii) patients' perspectives of their decision-making when invited to participate in the trial and (iv) recommending improvements to optimize future phase III trials.

Methods: A single-center, prospective, randomized, pilot study (KEATING), with an embedded qualitative design. Twelve newly diagnosed patients with GBM were randomized 1:1 to modified ketogenic diet (MKD) or medium chain triglyceride ketogenic diet (MCTKD). Primary outcome was retention at three months. Semi-structured interviews were conducted with a purposive sample of patients and caregivers (n = 15). Descriptive statistics were used for quantitative outcomes and qualitative data were analyzed thematically aided by NVivo.

Results: KEATING achieved recruitment targets, but the recruitment rate was low (28.6%). Retention was poor; only four of 12 patients completed the three-month diet (MCTKD n = 3; MKD n = 1). Participants' decisions were intuitive and emotional; caregivers supported diet implementation and influenced the patients' decision to participate. Those who declined made a deliberative and considered decision factoring diet burden and quality of life. A three-month diet was undesirable to patients who declined and withdrew.

Conclusion: Recruitment to a KD trial for patients with GBM is possible. A six-week intervention period is proposed for a phase III trial. The role of caregivers should not be underestimated. Future trials should optimize and adequately support the decision-making of patients.

Keywords: Feasibility; Glioblastoma; Ketogenic diet; Mixed-method; Pilot.

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Conflict of interest statement

KJM received a PhD studentship from Vitaflo (International) Ltd.

Figures

Fig. 1
Fig. 1
CONSORT diagram for KEATING
Fig. 2
Fig. 2
Progression free and overall survival of patients who commenced diet (MCT KD n = 5; MKD n = 5)
See this image and copyright information in PMC

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