Kirsty J Martin-McGill1,2, Anthony G Marson3,4, Catrin Tudur Smith5, Bridget Young6, Samantha J Mills4, M Gemma Cherry7,8, Michael D Jenkinson3,4. 1. Institute of Translational Medicine, University of Liverpool, Brownlow Hill, Liverpool, L69 3BX, UK. Kirsty.martin@liverpool.ac.uk. 2. Department of Clinical Sciences and Nutrition, University of Chester, Chester, UK. Kirsty.martin@liverpool.ac.uk. 3. Institute of Translational Medicine, University of Liverpool, Brownlow Hill, Liverpool, L69 3BX, UK. 4. The Walton Centre NHS Foundation Trust, Lower Lane, Liverpool, L9 7LJ, UK. 5. Department of Biostatistics, University of Liverpool, Brownlow Hill, Liverpool, L69 3BX, UK. 6. Department of Health Services Research, University of Liverpool, Brownlow Hill, Liverpool, L69 3BX, UK. 7. Department of Psychological Sciences, University of Liverpool, Brownlow Hill, Liverpool, L69 3BX, UK. 8. Clinical Health Psychology Service, Royal Liverpool University Hospital, Liverpool, L7 8XP, UK.
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.
RCT Entities:
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.
Entities:
Keywords:
Feasibility; Glioblastoma; Ketogenic diet; Mixed-method; Pilot
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