Back to resultsKetogenic Diet Adjunctive to Salvage Chemotherapy for Recurrent Glioblastoma:a Pilot Study (KGDinrGBM)
Primary Purpose
Glioblastoma Multiforme
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Ketogenic diet
Standard diet
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring ketogenic diet, recurrent glioblastoma, chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Age 18-60
- Karnovsky Performance Score of 60 or more.
- histologically confirmed glioblastoma multiforme, grade 4
- Ability and willingness to signed informed consent form.
- Documented recurrence or progression after surgical resection/debulking, radiation and temozolomide chemotherapy.
- normal function of liver and kidney
Exclusion Criteria:
- 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 uncontrolled hyperlipidemia or hyperglycemia.
- History of human immunodeficiency virus, or hepatitis C
- Pregnancy or breastfeeding
- Inability or unwillingness of subject to give written informed consent
Sites / Locations
- Beijing Tiantan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
ketogenic diet group
Standard diet group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of Participants with Treatment-emergent Adverse Effects
Number of participants with treatment-emergent adverse effects while on ketogenic diet.
Secondary Outcome Measures
The Chemosensitivity of Tumor
MRI(Magnetic Resonance Imaging) will be used to measure changes in brain tumor size (cm^2).
Overall Survival
Participants were followed until reported death
Ketosis
Urine and blood ketosis (mmol/L) were measured
Quality of Life
quality of life measured by the Karnofsky Performance Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02939378
Brief Title
Ketogenic Diet Adjunctive to Salvage Chemotherapy for Recurrent Glioblastoma:a Pilot Study
Acronym
KGDinrGBM
Official Title
Ketogenic Diet Adjunctive to Salvage Chemotherapy for Recurrent Glioblastoma:a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Song Lin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
Keywords
ketogenic diet, recurrent glioblastoma, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ketogenic diet group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard diet group
Arm Type
Other
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketogenic diet
Intervention Description
Ketogenic diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard diet
Intervention Description
Standard diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.
Primary Outcome Measure Information:
Title
Number of Participants with Treatment-emergent Adverse Effects
Description
Number of participants with treatment-emergent adverse effects while on ketogenic diet.
Time Frame
one year
Secondary Outcome Measure Information:
Title
The Chemosensitivity of Tumor
Description
MRI(Magnetic Resonance Imaging) will be used to measure changes in brain tumor size (cm^2).
Time Frame
one year
Title
Overall Survival
Description
Participants were followed until reported death
Time Frame
one year
Title
Ketosis
Description
Urine and blood ketosis (mmol/L) were measured
Time Frame
one year
Title
Quality of Life
Description
quality of life measured by the Karnofsky Performance Scale
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-60
Karnovsky Performance Score of 60 or more.
histologically confirmed glioblastoma multiforme, grade 4
Ability and willingness to signed informed consent form.
Documented recurrence or progression after surgical resection/debulking, radiation and temozolomide chemotherapy.
normal function of liver and kidney
Exclusion Criteria:
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 uncontrolled hyperlipidemia or hyperglycemia.
History of human immunodeficiency virus, or hepatitis C
Pregnancy or breastfeeding
Inability or unwillingness of subject to give written informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Song Lin, M.D.,
Phone
+8601067096509
Email
linsong2005@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaohui Ren, M.D.,
Phone
+8601067096509
Email
xiaohuiren@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Song Lin, M.D.,
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Song Lin, M.D.,
Phone
+8601067096509
Email
linsong2005@126.com
First Name & Middle Initial & Last Name & Degree
Xiaohui Ren, M.D.,
Phone
+8601067096509
Email
xiaohuiren@aliyun.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Ketogenic Diet Adjunctive to Salvage Chemotherapy for Recurrent Glioblastoma:a Pilot Study
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