Ketogenic Diet for Patients Receiving Treatment for Metastatic Renal Cell Carcinoma

Prior treatment

• Important surgical procedure within the 4 weeks before treatment
• Prior radiotherapy must have been completed at least 2 weeks prior to treatment
• 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
• Concomitant treatments : strong inducers of CYP3A4 (DEXAMETHASONE, PHENYTOINE, CARBAMAZEPINE, RIFAMPICINE, RIFABUTINE, RIFAPENTINE, PHENOBARBITAL, and ST. JOHN'S WORT)

Other illness

• Swallowing disorder
• 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
• Any serious or uncontrolled medical disorder during the last 6 months : hepatic insufficiency, renal insufficiency, respiratory insufficiency
• Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
• Malabsorption syndrome
• Uncontrolled infection
• Social, psychological or medical condition that may interfere with participation in the study or its evaluation
• Patient with psychiatric treatment under duress

Lab values

• QT/QTc interval \> 450 msec for men and \> 470 msec for women

Other

• Any contraindication to a ketogenic diet : primary carnitine deficiency, fatty acid beta-oxidation and cytogenesis deficiencies, pyruvate carboxylate deficiency, porphyria
• Pregnant women or breastfeeding
• Subjects with symptomatics 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)
• Patient deprived of liberty by judicial or administrative decision
• Patient subject to legal protection measures
• Patient unable to give informed consent.

• Subject with histologically-confirmed renal cell carcinoma
• At least one CT-verified metastasis ≥ 10 mm, not previously irradiated
• Treatment : PAZOPANIB, SUNITINIB, PEMBROLIZUMAB/AXITINIB or NIVOLUMAB/IPILIMUMAB (for first line), NIVOLUMAB, CABOZANTINIB, AXITINIB, SORAFENIB, TKI anti-VEGF, other therapy for second and third line of treatment
• 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