Status:
COMPLETED
Ketogenic Diet for Patients Receiving Treatment for Metastatic Renal Cell Carcinoma
Lead Sponsor:
University Hospital, Angers
Collaborating Sponsors:
Vitaflo International, Ltd
Conditions:
Metastatic Renal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 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)
- 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.
Key Trial Info
Start Date :
July 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04316520
Start Date
July 22 2020
End Date
March 6 2024
Last Update
August 16 2024
Active Locations (1)
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1
CHU Angers
Angers, France