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

Primary Purpose

Metastatic Renal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ketogenic diet
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Renal Cancer focused on measuring metastatic renal cancer, ketogenic diet, immunotherapy, first line treatment, targeted therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU AngersRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketogenic diet

Arm Description

Ketogenic diet + standard of care

Outcomes

Primary Outcome Measures

Tolerance of one year of ketogenic diet 2:1
Frequency of adverse events evaluation

Secondary Outcome Measures

Compliance of ketogenic diet
Pourcentage of compliant patients
Progression free survival according to RECIST 1.1 at 2 years
Assessed by RECIST 1.1
Overall survival at 2 years
Assessed by RECIST 1.1

Full Information

First Posted
March 18, 2020
Last Updated
September 16, 2020
Sponsor
University Hospital, Angers
Collaborators
Vitaflo International, Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04316520
Brief Title
Ketogenic Diet for Patients Receiving First Line Treatment for Metastatic Renal Cell Carcinoma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2020 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
Collaborators
Vitaflo International, Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cancer
Keywords
metastatic renal cancer, ketogenic diet, immunotherapy, first line treatment, targeted therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketogenic diet
Arm Type
Experimental
Arm Description
Ketogenic diet + standard of care
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketogenic diet
Other Intervention Name(s)
First line treatment
Intervention Description
Ketogenic diet 2:1
Primary Outcome Measure Information:
Title
Tolerance of one year of ketogenic diet 2:1
Description
Frequency of adverse events evaluation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Compliance of ketogenic diet
Description
Pourcentage of compliant patients
Time Frame
1 year
Title
Progression free survival according to RECIST 1.1 at 2 years
Description
Assessed by RECIST 1.1
Time Frame
2 years
Title
Overall survival at 2 years
Description
Assessed by RECIST 1.1
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre BIGOT, MD PhD
Phone
+33241356494
Email
pibigot@chu-angers.fr
Facility Information:
Facility Name
CHU Angers
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre BIGOT
Email
pierre.bigot@chu-angers.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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