Ketogenic Diet Adjunctive to Salvage Chemotherapy for Recurrent Glioblastoma:a Pilot Study (KGDinrGBM)
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|ClinicalTrials.gov Identifier: NCT02939378|
Recruitment Status : Unknown
Verified October 2016 by Song Lin, Beijing Tiantan Hospital.
Recruitment status was: Recruiting
First Posted : October 20, 2016
Last Update Posted : October 20, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Dietary Supplement: Ketogenic diet Dietary Supplement: Standard diet||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ketogenic Diet Adjunctive to Salvage Chemotherapy for Recurrent Glioblastoma:a Pilot Study|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
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.
Dietary Supplement: Ketogenic diet
Ketogenic diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.
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.
Dietary Supplement: Standard diet
Standard diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.
- Number of Participants with Treatment-emergent Adverse Effects [ Time Frame: one year ]Number of participants with treatment-emergent adverse effects while on ketogenic diet.
- The Chemosensitivity of Tumor [ Time Frame: one year ]MRI(Magnetic Resonance Imaging) will be used to measure changes in brain tumor size (cm^2).
- Overall Survival [ Time Frame: one year ]Participants were followed until reported death
- Ketosis [ Time Frame: one year ]Urine and blood ketosis (mmol/L) were measured
- Quality of Life [ Time Frame: one year ]quality of life measured by the Karnofsky Performance Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939378
|Contact: Song Lin, M.D.,||+email@example.com|
|Contact: Xiaohui Ren, M.D.,||+firstname.lastname@example.org|
|Principal Investigator:||Song Lin, M.D.,||Beijing Tiantan Hospital|