Clinical trial NCT03160599: Restricted Calorie Ketogenic Diet as a Treatment in Malignant Tumors
Official title: Restricted Calorie Ketogenic Diet as a Treatment in Glioblastoma Multiforme: a Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignant Tumors
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. 40 patients with diagnosed/recurrent malignant tumors
2. Ability and willingness to sign informed consent form.

Exclusion Criteria:

1. Anticoagulation treatment with coumadin≥ 1 mg/day for ≤ 7 days prior to screening (low-dose \[≤ 1 mg/day\] coumadin, heparin, and low-molecular-weight heparin are permitted)
2. Any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, carnitine deficiency and pancreatitis
3. History of malignant tumors other than malignant glioma, such as surgical resection of non-melanoma skin cancer or cervical carcinoma in situ.
4. History of uncontrollable hyperlipidemia.
5. Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators, would interfere with adherence to study requirements
6. History of having human immunodeficiency virus, or hepatitis C
7. Failure to recover from \<CTCAE grade 2 toxicities related to prior therapy
8. Pregnancy or breastfeeding.
9. Use of any investigational drug within 1 months of enrollment
10. Inability or unwillingness of subject to give written informed consent

Primary outcomes:
measure: Adverse events of patients on high-fat diet
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References: