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

September 16, 2020 updated by: University Hospital, Angers

A Pilot Study Evaluating the Tolerability of a Ketogenic Diet With Vitamin Supplementation for Patients Receiving First Line Treatment for Metastatic Renal Cell Carcinoma

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.

Study Overview

Status

Recruiting

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

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • First line treatment

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2020

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

March 18, 2020

First Submitted That Met QC Criteria

March 18, 2020

First Posted (Actual)

March 20, 2020

Study Record Updates

Last Update Posted (Actual)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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