- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04316520
Ketogenic Diet for Patients Receiving First Line Treatment for Metastatic Renal Cell Carcinoma (CETOREIN)
A Pilot Study Evaluating the Tolerability of a Ketogenic Diet With Vitamin Supplementation for Patients Receiving First Line Treatment for Metastatic Renal Cell Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pierre BIGOT, MD PhD
- Phone Number: +33241356494
- Email: pibigot@chu-angers.fr
Study Locations
-
-
-
Angers, France
- Recruiting
- CHU Angers
-
Contact:
- Pierre BIGOT
- Email: pierre.bigot@chu-angers.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject with histologically-confirmed renal cell carcinoma
- At least one CT-verified metastasis ≥ 10 mm, not previously irradiated
- First line treatment : PAZOPANIB, SUNITINIB, PEMBROLIZUMAB/AXITINIB or NIVOLUMAB/IPILIMUMAB
- No prior treatment for the metastatic renal cell carcinoma
- Men and women, aged ≥ 18 years
- OMS ≤ 1
Screening laboratory values must meet the following criteria and should be obtained prior to commencement of treatment:
- Hemoglobin ≥ 9 g/dL, neutrophils ≥ 1000 /mm3, platelets ≥ 100 000 /mm3, leukocytes ≥ 2000 /mm3
- Total bilirubin ≤ 1,5 ULN, ASAT and ALAT ≤ 3 x ULN
- Creatinine clearance ≥ 30 mL/min, verified proteinuria above or equal to 1g/24 hours measured from 24 hours of urine if the urinary protein
- Corrected calcium ≤ ULN
- Patient must have signed and dated informed consent
- Patient must have an internet connection
Exclusion Criteria:
- Any contraindication to a ketogenic diet : primary carnitine deficiency, fatty acid beta-oxidation and cytogenesis deficiencies, pyruvate carboxylate deficiency, porphyria
- Swallowing disorder
- Important surgical procedure within the 4 weeks before treatment
- Prior radiotherapy must have been completed at least 2 weeks prior to treatment
- Pregnant women or breastfeeding
- Subjects with previous malignancies (except non-melanoma skin cancer and the following endometrial in situ cancers) are excluded unless a complete remission was achieved at least 3 years prior to study entry and no additional therapy is required during the study period
- Subjects with brain metastases, uncontrolled compression of the spinal cord, carcinomatous meningitis, signs of cerebral or leptomeningeal involvement
- Uncontrolled blood pressure (SBP >150 mmH et DBP >100 mmHg)
- Any serious or uncontrolled medical disorder during the last 6 months : hepatic insufficiency, renal insufficiency, respiratory insufficiency
- Patients with any severe medical conditions within 6 month prior to inclusion such as : myocardial infarction, severe/instable angina pectoris, coronary artery bypass surgery, NYHA III or IV congestive heart failure, stroke or transient ischemic attack
- Patients with sere medical conditions within 3 month prior to inclusion such as : grade 3 or grade 4 gastrointestinal bleeding, peptic ulcer treatment resistant, esophagitis or ulcerated gastritis, infectious or inflammatory bowel disease, diverticulitis, thrombosis, pulmonary embolism or other uncontrolled thromboembolic event, unhealed bone fractures
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- Malabsorption syndrome
- Uncontrolled infection
- QT/QTc interval > 450 msec for men and > 470 msec for women
- Concomitant treatments : strong inducers of CYP3A4 (DEXAMETHASONE, PHENYTOINE, CARBAMAZEPINE, RIFAMPICINE, RIFABUTINE, RIFAPENTINE, PHENOBARBITAL, and ST. JOHN'S WORT)
- Social, psychological or medical condition that may interfere with participation in the study or its evaluation
- Patient deprived of liberty by judicial or administrative decision
- Patient with psychiatric treatment under duress
- Patient subject to legal protection measures
- Patient unable to give informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketogenic diet
Ketogenic diet + standard of care
|
Ketogenic diet 2:1
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerance of one year of ketogenic diet 2:1
Time Frame: 1 year
|
Frequency of adverse events evaluation
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compliance of ketogenic diet
Time Frame: 1 year
|
Pourcentage of compliant patients
|
1 year
|
Progression free survival according to RECIST 1.1 at 2 years
Time Frame: 2 years
|
Assessed by RECIST 1.1
|
2 years
|
Overall survival at 2 years
Time Frame: 2 years
|
Assessed by RECIST 1.1
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 49RC19_0181
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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