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Ketogenic diets as an adjuvant therapy for glioblastoma (KEATING): a randomized, mixed methods, feasibility study
Martin-McGill, Kirsty J. Marson, Anthony Tudur Smith, Catrin Young, Bridget Mills, Samantha Cherry, M. Gemma Jenkinson, Michael
Martin-McGill, Kirsty J.
Marson, Anthony
Tudur Smith, Catrin
Young, Bridget
Mills, Samantha
Cherry, M. Gemma
Jenkinson, Michael
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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 modifed 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 infuenced 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 caregiver should not be underestimated. Future trials should optimize and adequately support
the decision-making of patients.
Citation
Martin-McGill, K, J., Marson, A, G., Tudor Smith, C., Young, B., Mills, S, J., Cherry, G. & Jenkinson, M, D. (2020). Ketogenic diets as an adjuvant therapy for glioblastoma (KEATING): A randomized, mixed methods, feasibility study, Journal of Neuro-Oncology, 147, 213–227
Publisher
Springer
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Journal of Neuro-Oncology
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Article
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This is a post-peer-review, pre-copyedit version of an article published in Journal of Neuro-Oncology. The final authenticated version is available online at: http://dx.doi.org/10.1007/s11060-020-03417-8
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1573-7373