The Effect of Ketogenic Diet on Malignant Tumors- Recurrence and Progress
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- To study the effect of the ketogenic diet on tumor growth progression and longevity in patients with Malignant glioblastoma.
研究概览
简要总结
The aim of the study is, to study the efficacy of the ketogenic diet in delaying or preventing recurrence and tumor growth progression of patients who have been previously treated by concomitant chemoradiotherapy (6 months) for high-grade glial tumors.
It will be an open-label trial of nutritional intervention for up to 1 year. An interim analysis of the data will be carried out to assess safety, compliance and efficacy of the diet. This will be reviewed by both SHS and the Clinical trial team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting adults aged ≥ 18 years.
- •Recurrent or progressive high grade glioma after failure of at least one line of standard oncological treatment.
- •Gliomatosis cerebri, including patients declining radiation treatment.
排除标准
- •Patients with malignant tumors who are receiving treatment at the time of the recruitment.
- •Early termination - patients who will wish to stop their participation in the trial will discontinue the ketogenic diet and return to their usual diet.
研究组 & 干预措施
Standard diet: Nutritional support
干预措施: Nutritional support with Standard diet (Other)
Nutritional intervention: Ketogenic diet.
干预措施: Nutritional intervention with the Ketogenic diet (Other)
结局指标
主要结局
To study the effect of the ketogenic diet on tumor growth progression and longevity in patients with Malignant glioblastoma.
This will be done by comparing tumor size by repeated MRI studies (every 2 months)
次要结局
- Quality of life