Ketogenic Diet for Patients Receiving First Line Treatment for Metastatic Renal Cell Carcinoma

Metastatic Renal Cancer Clinical Trial

— CETOREIN  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04316520
• Other study ID #: 49RC19_0181
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2020
• Est. completion date: May 2024

Study information

• Verified date: March 2020
• Source: University Hospital, Angers
• Contact: Pierre BIGOT, MD PhD
• Phone: +33241356494
• Email: pibigot[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2024
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject with histologically-confirmed renal cell carcinoma

2. At least one CT-verified metastasis = 10 mm, not previously irradiated

3. First line treatment : PAZOPANIB, SUNITINIB, PEMBROLIZUMAB/AXITINIB or NIVOLUMAB/IPILIMUMAB

4. No prior treatment for the metastatic renal cell carcinoma

5. Men and women, aged = 18 years

6. OMS = 1

7. Screening laboratory values must meet the following criteria and should be obtained prior to commencement of treatment:

1. Hemoglobin = 9 g/dL, neutrophils = 1000 /mm3, platelets = 100 000 /mm3, leukocytes = 2000 /mm3

2. Total bilirubin = 1,5 ULN, ASAT and ALAT = 3 x ULN

3. Creatinine clearance = 30 mL/min, verified proteinuria above or equal to 1g/24 hours measured from 24 hours of urine if the urinary protein

4. Corrected calcium = ULN

8. Patient must have signed and dated informed consent

9. Patient must have an internet connection

Exclusion Criteria:

1. Any contraindication to a ketogenic diet : primary carnitine deficiency, fatty acid beta-oxidation and cytogenesis deficiencies, pyruvate carboxylate deficiency, porphyria

2. Swallowing disorder

3. Important surgical procedure within the 4 weeks before treatment

4. Prior radiotherapy must have been completed at least 2 weeks prior to treatment

5. Pregnant women or breastfeeding

6. 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

7. Subjects with brain metastases, uncontrolled compression of the spinal cord, carcinomatous meningitis, signs of cerebral or leptomeningeal involvement

8. Uncontrolled blood pressure (SBP >150 mmH et DBP >100 mmHg)

9. Any serious or uncontrolled medical disorder during the last 6 months : hepatic insufficiency, renal insufficiency, respiratory insufficiency

10. 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

11. 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

12. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)

13. Malabsorption syndrome

14. Uncontrolled infection

15. QT/QTc interval > 450 msec for men and > 470 msec for women

16. Concomitant treatments : strong inducers of CYP3A4 (DEXAMETHASONE, PHENYTOINE, CARBAMAZEPINE, RIFAMPICINE, RIFABUTINE, RIFAPENTINE, PHENOBARBITAL, and ST. JOHN'S WORT)

17. Social, psychological or medical condition that may interfere with participation in the study or its evaluation

18. Patient deprived of liberty by judicial or administrative decision

19. Patient with psychiatric treatment under duress

20. Patient subject to legal protection measures

21. Patient unable to give informed consent.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Metastatic Renal Cancer

Intervention

Dietary Supplement:
• Ketogenic diet
Ketogenic diet 2:1

Locations

Country	Name	City	State
France	CHU Angers	Angers

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Angers	Vitaflo International, Ltd

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance of one year of ketogenic diet 2:1	Frequency of adverse events evaluation	1 year
Secondary	Compliance of ketogenic diet	Pourcentage of compliant patients	1 year
Secondary	Progression free survival according to RECIST 1.1 at 2 years	Assessed by RECIST 1.1	2 years
Secondary	Overall survival at 2 years	Assessed by RECIST 1.1	2 years