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

  • STATUS
    Recruiting
  • End date
    May 26, 2024
  • participants needed
    20
  • sponsor
    University Hospital, Angers
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Updated on 26 January 2021
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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.

Details
Condition Metastatic Renal Cancer
Treatment Ketogenic diet
Clinical Study IdentifierNCT04316520
SponsorUniversity Hospital, Angers
Last Modified on26 January 2021

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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