NCT04316520

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 22, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2024

Completed
Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

2.5 years

First QC Date

March 18, 2020

Last Update Submit

August 13, 2024

Conditions

Metastatic Renal Cancer

Keywords

metastatic renal cancerketogenic dietimmunotherapyfirst line treatmenttargeted therapy

Outcome Measures

Primary Outcomes (1)

  • Tolerance of one year of ketogenic diet 2:1

    Frequency of adverse events evaluation

    1 year

Secondary Outcomes (3)

  • Compliance of ketogenic diet

    1 year

  • Progression free survival according to RECIST 1.1 at 2 years

    2 years

  • Overall survival at 2 years

    2 years

Study Arms (1)

Ketogenic diet

EXPERIMENTAL

Ketogenic diet + standard of care

Dietary Supplement: Ketogenic diet

Interventions

Ketogenic dietDIETARY_SUPPLEMENT

Ketogenic diet 2:1

Also known as: First line treatment
Ketogenic diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Angers

Angers, France

Location

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2020

First Posted

March 20, 2020

Study Start

July 22, 2020

Primary Completion

January 6, 2023

Study Completion

March 6, 2024

Last Updated

August 16, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)