Restricted Calorie Ketogenic Diet as a Treatment in Malignant Tumors

NCT ID: NCT03160599

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2020-12-01

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.

Conditions

Malignant Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Restricted Calorie Ketogenic Diet

Calorie restriction: The basis of dietary design is 70-85% of individual's total calories. The total calorie is based on patient's activity level and their basal metabolism values, which is obtained from indirect calorimetry or harris-benedict formula.

Treatment will consist of ketogenic diet. KD will consist of 4:1-1:1[fat]:[protein+carbohydrate].Carbohydrate is limited to 10-30 g / day.The diet will be supplemented with vitamins, calcium, phosphorus, zinc and selenium supplements to meet the requirements of US Dietary Reference Intakes (DRI) standard.

Group Type: EXPERIMENTAL

ketogenic diet

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yu Hong Deng, M.D.

Role: CONTACT

1376708863@qq.com

86 20 81340031

Facility Contacts

Qian Chen

Role: primary

86 20 81340031

Other Identifiers

LCYY

Identifier Type: -

Identifier Source: org_study_id