Ketogenic Diets as an Adjuvant Therapy in Glioblastoma: A Randomised Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- To assess retention and drop out rates
研究概览
简要总结
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.
详细描述
A prospective, non-blinded, randomized, pilot study will be undertaken in patients with glioblastoma (GB). Patients will be randomized to the modified ketogenic diet (MKD) or the medium chain triglyceride ketogenic diet (MCT) for a 12 week period (primary completion). If patients wish to remain on diet, they will be offered dietetic support for a total of 12 months (secondary completion).
The trial will be open to all Walton Centre Foundation Trust patients with a newly diagnosed GB, who have undergone surgical resection or biopsy within the last four months and who are going on to receive/ are currently receiving/ have completed oncological treatments (radiotherapy or chemotherapy or chemoradiotherapy). Patients will be referred via neuro-oncology multi-disciplinary meetings and neurosurgical clinics, post histology. The diet will be offered alongside standard care, commencing within four months of surgery.
Both diets are high in fat and low in carbohydrate, but contain different types and amounts of fats. The MKD is 80% fat (predominately long chain fatty acids) and 5% carbohydrate, whilst the MCT diet is 75% fat (30% of which is medium chain fatty acids) and 10% carbohydrate.
A permuted block randomization method will be adopted, using 'sealedenvelope' randomization system. This will be set up and administered by the statistician, who is not involved with the recruiting of patients.
Patients will receive regular input from the trial dietitian. This includes clinical consultations at baseline, dietary initiation, week 6, week 12 and every 3 months thereafter and telephone consultations at weeks 1, 3 and 9. Patients will receive dietary and ketone monitoring education.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Modified ketogenic diet (MKD)
MKD: 80% fat and 5% carbohydrate (% of total energy requirements per day).
干预措施: MKD (Other)
Medium chain triglyceride (MCT) diet
MCT: 75% fat (30% of which is medium chain fatty acids taken as a supplement) and 5% carbohydrate (% of total energy requirements per day).
干预措施: MCT (Other)
结局指标
主要结局
To assess retention and drop out rates
时间窗: 12 weeks
Number of patients who start randomized treatment as a proportion of the number randomized ;
次要结局
- Completeness of data(2 years)
- Long term retention(2 years)
- Estimation of recruitment rates(12 months)
- Dietary adjustments required to achieve ketosis(2 years)
- Self reported dietary compliance(2 years)
- Protocol refinements required(2 years)
- Dietetic time required for interventions(2 years)
- Gastrointestinal side effects(2 years)
- Sample size estimates for future trials(2 years)
- Food acceptability(2 years)
- Calculated dietary compliance(2 years)
- MCT compliance(2 years)
- Ketosis levels(2 years)
- Quality of life(2 years)
- Anthropometric changes(2 years)
- Changes to biochemical markers(2 years)
- Enrollment of patients(12 months)
研究者
Michael Jenkinson
Chief Investigator
University of Liverpool