A Phase 1/2 interventional study of Ketogenic diet and Standard diet in Glioblastoma Multiforme, sponsored by Song Lin. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-10-20.
Sponsored by Song Lin · Phase 1/2, Interventional, and Treatment
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.
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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's planned enrollment of 60 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →This is the only study on the registry with Song Lin as lead sponsor.
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Exclusion Criteria:
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.
Dietary Supplement: Ketogenic diet
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.
Dietary Supplement: Standard diet
Ketogenic diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.
Standard diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.
Number of Participants with Treatment-emergent Adverse Effects
Number of participants with treatment-emergent adverse effects while on ketogenic diet.
Time frame: one year
The Chemosensitivity of Tumor
MRI(Magnetic Resonance Imaging) will be used to measure changes in brain tumor size (cm\^2).
Time frame: one year
Overall Survival
Participants were followed until reported death
Time frame: one year
Ketosis
Urine and blood ketosis (mmol/L) were measured
Time frame: one year
Quality of Life
quality of life measured by the Karnofsky Performance Scale
Time frame: one year
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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