home/imdoinit.org

Ketogenic Diet Adjunctive to Salvage Chemotherapy for Recurrent Glioblastoma:a Pilot Study

Study Purpose

Recently, ketogenic diet has been recognized a useful treatment strategy for glioblastoma in vitro. Therefore, the purpose of the study is to evaluate the safety and efficacy of ketogenic adjuvant to salvage chemotherapy for recurrent glioblastoma.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 60 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age 18-60. 2. Karnovsky Performance Score of 60 or more. 3. histologically confirmed glioblastoma multiforme, grade 4. 4. Ability and willingness to signed informed consent form. 5. Documented recurrence or progression after surgical resection/debulking, radiation and temozolomide chemotherapy. 6. normal function of liver and kidney.

Exclusion Criteria:

1. 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. 2. History of uncontrolled hyperlipidemia or hyperglycemia. 3. History of human immunodeficiency virus, or hepatitis C. 4. Pregnancy or breastfeeding. 5. Inability or unwillingness of subject to give written informed consent

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02939378
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Song Lin
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Song Lin, M.D.,
Principal Investigator Affiliation	Beijing Tiantan Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Unknown status
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma Multiforme

Additional Details

Diet change by limiting carbohydrates and increasing the proportion of fatty acids and proteins can lead to ketogenic metabolism and might limit energy production in tumor cells and inhibit tumor growth. In a pilot of recurrent glioblastoma, ketogenic diet adjuvant salvage chemotherapy was given as interventional group and standard diet adjuvant salvage chemotherapy was given as control group. The study examines whether a ketogenic diet adjunctive to salvage chemotherapy can be applied to the patients and may inhibit tumor growth and influence the quality of life of the patients.

Arms & Interventions

Arms

Experimental: ketogenic diet group

Ketogenic diet adjuvant to salvage chemotherapy was given to recurrent glioblastoma. Blood glucose and ketone were kept more than 2mmol/L during salvage chemotherapy. The side effect was observed and recorded. Tumor volume was monitored and the efficacy was recorded.

Other: Standard diet group

Standard diet adjuvant to salvage chemotherapy was given to recurrent glioblastoma. Blood glucose and ketone were recorded during salvage chemotherapy. The side effect was observed and recorded. Tumor volume was monitored and the efficacy was recorded.

Interventions

Dietary Supplement: - Ketogenic diet

Ketogenic diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.

Dietary Supplement: - Standard diet

Standard diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing Tiantan Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Beijing Tiantan Hospital

Beijing, Beijing, 100005

Site Contact

Song Lin, M.D.,

[email protected]

+8601067096509

Clinical Trial Finder