Trials / Completed
CompletedNCT04316520
Ketogenic Diet for Patients Receiving Treatment for Metastatic Renal Cell Carcinoma
A Pilot Study Evaluating the Tolerability of a Ketogenic Diet With Vitamin Supplementation for Patients Receiving Treatment for Metastatic Renal Cell Carcinoma
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University Hospital, Angers · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the tolerance of one year of ketogenic diet associated with vitamin supplementation in patients treated for a metastatic renal cell carcinoma.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Ketogenic diet | Ketogenic diet 2:1 |
Timeline
- Start date
- 2020-07-22
- Primary completion
- 2023-01-06
- Completion
- 2024-03-06
- First posted
- 2020-03-20
- Last updated
- 2024-08-16
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04316520. Inclusion in this directory is not an endorsement.