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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04316520
Recruitment Status : Not yet recruiting
First Posted : March 20, 2020
Last Update Posted : March 31, 2020
Sponsor:
Collaborator:
Vitaflo International, Ltd
Information provided by (Responsible Party):
University Hospital, Angers

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Renal Cancer Dietary Supplement: Ketogenic diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Ketogenic diet
Ketogenic diet + standard of care
Dietary Supplement: Ketogenic diet
Ketogenic diet 2:1
Other Name: First line treatment




Primary Outcome Measures :
  1. Tolerance of one year of ketogenic diet 2:1 [ Time Frame: 1 year ]
    Frequency of adverse events evaluation


Secondary Outcome Measures :
  1. Compliance of ketogenic diet [ Time Frame: 1 year ]
    Pourcentage of compliant patients

  2. Progression free survival according to RECIST 1.1 at 2 years [ Time Frame: 2 years ]
    Assessed by RECIST 1.1

  3. Overall survival at 2 years [ Time Frame: 2 years ]
    Assessed by RECIST 1.1



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Pierre BIGOT, MD PhD +33241356494 pibigot@chu-angers.fr

Sponsors and Collaborators
University Hospital, Angers
Vitaflo International, Ltd
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT04316520    
Other Study ID Numbers: 49RC19_0181
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Angers:
metastatic renal cancer
ketogenic diet
immunotherapy
first line treatment
targeted therapy
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases