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.

中文翻译：

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生酮饮食作为胶质母细胞瘤的辅助疗法（KEATING）：随机，混合方法，可行性研究。

目的我们进行了可行性研究，以调查生酮饮食（KDs）作为胶质母细胞瘤（GBM）患者的辅助治疗方法，以调查（i）试验可行性；（ii）该试验对患者生活质量和健康的潜在影响；（iii）患者受邀参加试验时的决策观点，以及（iv）提出改进建议以优化未来的III期试验。方法采用嵌入式定性设计的单中心，前瞻性，随机，前瞻性研究（KEATING）。12名新诊断的GBM患者按1：1比例随机分配改良生酮饮食（MKD）或中链甘油三酸酯生酮饮食（MCTKD）。主要结果是保留三个月。采用针对性的患者和护理人员样本（n = 15）进行半结构式访谈。描述性统计用于定量结果，定性数据在NVivo的帮助下进行了主题分析。结果济亭实现了招募目标，但招募率较低（28.6％）。保留能力差；12名患者中只有4名完成了为期三个月的饮食（MCTKD n = 3； MKD n = 1）。参与者的决定是直觉和情感的；照顾者支持饮食的实施，并影响了患者的参与决策。那些拒绝的人进行了审议，并考虑了饮食负担和生活质量的决定。对于拒绝和退出的患者，三个月的饮食是不可取的。结论GBM患者可以参加KD试验。对于III期临床试验，建议进行6周的干预。照顾者的作用不应低估。