Malignant TumorsNCT03160599
Restricted Calorie Ketogenic Diet as a Treatment in Malignant Tumors
A study testing ketogenic diet in people with Malignant Tumors, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Malignant Tumors
- What is being tested?
- ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 40 patients with diagnosed/recurrent malignant tumors
- Ability and willingness to sign informed consent form.
Who cannot join
- 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)
- 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
- History of malignant tumors other than malignant glioma, such as surgical resection of non-melanoma skin cancer or cervical carcinoma in situ.
- History of uncontrollable hyperlipidemia.
- Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators, would interfere with adherence to study requirements
- History of having human immunodeficiency virus, or hepatitis C
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- Failure to recover from <CTCAE grade 2 toxicities related to prior therapy
- Pregnancy or breastfeeding.
- Use of any investigational drug within 1 months of enrollment
- Inability or unwillingness of subject to give written informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Qian Chen, 86 20 81340031
About this study
Official title: Restricted Calorie Ketogenic Diet as a Treatment in Glioblastoma Multiforme: a Clinical Study
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
- Being tested
- ketogenic diet
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketogenic dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Restricted Calorie Ketogenic Diet | Experimental | 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. Receives: Other: ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events of patients on high-fat diet
The main focus of this period is to recruit patients and collect clinical data for patients with glioblastoma multiforme on restricted calorie ketogenic diet. The safety and tolerability of the treatment will be evaluated.This can be measured by reports of adverse incidences.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start1 Mar 2018
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160599
- Sponsor's protocol ID
- LCYY
- Status last verified
- Sep 2018
- First submitted
- 2 May 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restricted Calorie Ketogenic Diet as a Treatment in Glioblastoma Multiforme: a Clinical Study
- ClinicalTrials.gov ID
- NCT03160599
- Acronym / sponsor ID
- LCYY
- Conditions
- Malignant Tumors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restricted Calorie Ketogenic Diet | Experimental | Other: ketogenic dietCalorie 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 40 patients with diagnosed/recurrent malignant tumors
- Ability and willingness to sign informed consent form.
Key exclusion criteria (10 listed)
- 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)
- 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
- History of malignant tumors other than malignant glioma, such as surgical resection of non-melanoma skin cancer or cervical carcinoma in situ.
- History of uncontrollable hyperlipidemia.
- Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators, would interfere with adherence to study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketogenic dietThe 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. | Other | Restricted Calorie Ketogenic Diet |
Primary outcome
Adverse events of patients on high-fat diet
Time frame: 2 year
The main focus of this period is to recruit patients and collect clinical data for patients with glioblastoma multiforme on restricted calorie ketogenic diet. The safety and tolerability of the treatment will be evaluated.This can be measured by reports of adverse incidences.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ketogenic diet in people with Malignant Tumors, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Hong Deng, M.D. (86 20 81340031, 1376708863@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events of patients on high-fat diet (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.