NCT03160599

Restricted Calorie Ketogenic Diet as a Treatment in Malignant Tumors

Restricted Calorie Ketogenic Diet as a Treatment in Glioblastoma Multiforme: a Clinical Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Malignant tumor incidence showed an upgrade trend in recent years. Standard therapy for malignant tumor includes surgery followed by radiation and chemotherapy. Despite optimal treatment the prognosis remains poor. There is an urgent need for more effective therapies. The Warburg effect has been widely observed in human cancers. The main energy supply of tumor cells are aerobic glycolysis. Therefore, they are highly dependent on glucose metabolism. Recently, some scholars have suggested that 'Restricted calorie Ketogenic Diet (RKD)' might be able to inhibit glycolysis and thus anti-tumor by restricting carbohydrate intake. This will 'starve' cancer cells, which will lead to cell death. There are many animal and in vitro studies shown that RKD can reduce the tumor size and thus tumor cell growth of malignant tumors. However, a consistent positive result can not be found within a small sample of clinical trials. In this study, 40 patients with malignant tumors will be treated with or without RKD. The safety and efficacy of RKD and the patients' tolerance will be observed in order to understand whether this therapy can be a potential new treatment This clinical study is comparatively large internationally. It is the first domestically. This study is essential to extend the survival of patients with malignant tumors, and to study clinical nutrition support and its metabolic pathways for malignant tumors.

Conditions

• Malignant Tumors

Interventions

Type	Name	Description
OTHER	ketogenic diet	The treatment is mainly restricted calorie ketogenic diet. KD will consist of 4:1-1:1\[fat\]:\[protein+carbohydrate\].Carbohydrate is limited to 10-30 g / day.

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-12-01
• Completion: 2020-12-01
• First posted: 2017-05-19
• Last updated: 2018-09-05

Locations

1 site across 1 country: China