Ketogenic Diet for Patients Receiving First Line Treatment for Metastatic Renal Cell Carcinoma (CETOREIN)
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|ClinicalTrials.gov Identifier: NCT04316520|
Recruitment Status : Not yet recruiting
First Posted : March 20, 2020
Last Update Posted : March 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Renal Cancer||Dietary Supplement: Ketogenic diet||Not Applicable|
This research study is a pilot study evaluating the tolerance of a ketogenic diet associated with a standard of care in patient with metastatic renal cell carcinoma.
The drugs involved in this study could be NIVOLUMAB + IPILIMUMAB, PEMBROLIZUMAB + AXITINIB, SUNITINIB or PAZOPANIB.
Cancer cells are known to have an increased glycolytic activity that allows them to product energy from anaerobic degradation of glucose. A ketogenic diet places the body in ketosis state. It forces the body to burn fat instead of glucose. Fat metabolism occurs via the mitochondrial oxidative phosphorylation. By reducing sugar intake and regulating energy metabolism, the ketogenic diet could contribute to limit tumor progression.
This diet will be introduced during one year, patient will be monitored closely with biological tests and radiological assessments every three month.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Evaluating the Tolerability of a Ketogenic Diet With Vitamin Supplementation for Patients Receiving First Line Treatment for Metastatic Renal Cell Carcinoma|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||May 2024|
Experimental: Ketogenic diet
Ketogenic diet + standard of care
Dietary Supplement: Ketogenic diet
Ketogenic diet 2:1
Other Name: First line treatment
- Tolerance of one year of ketogenic diet 2:1 [ Time Frame: 1 year ]Frequency of adverse events evaluation
- Compliance of ketogenic diet [ Time Frame: 1 year ]Pourcentage of compliant patients
- Progression free survival according to RECIST 1.1 at 2 years [ Time Frame: 2 years ]Assessed by RECIST 1.1
- Overall survival at 2 years [ Time Frame: 2 years ]Assessed by RECIST 1.1
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): NCT04316520
|Contact: Pierre BIGOT, MD PhDemail@example.com|