Clareo Health | Single-Center Trial on Ketogenic Diet and Immunotherapy in Advanced Cancer This Study Evaluates the Safety and Effects of a Ketogenic Diet (KD) Combined With Immunotherapy in Adults With Advanced Melanoma, cSCC, or RCC.
Single-Center Trial on Ketogenic Diet and Immunotherapy in Advanced Cancer This Study Evaluates the Safety and Effects of a Ketogenic Diet (KD) Combined With Immunotherapy in Adults With Advanced Melanoma, cSCC, or RCC.
* Patients with a histologically confirmed melanoma or cSCC or RCC receiving first line treatment with combination nivolumab and ipilimumab /relatlimab or single agent ipilimumab, nivolumab, pembrolizumab, Cemiplimab.
* Able to read, understand, and provide written informed consent
* Willing and able to complete all study-specific procedures and visits
* Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
* Blood tests:
* Creatinine (Cr) \< 1.5 mg/dL.
* Magnesium normal range ( 1.5 -2,6 mg/dL)
* Liver function tests (LFTs) 2.5x upper limit of normal (ULN).
* Women of childbearing potential must have a negative β-HCG pregnancy test documented within 1 week of registration.
You may not be if
• Individuals \< 18 years of age
* Unable or unwilling to provide consent
* Other active malignancy (other than adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or any other cancer from which the patient has been disease free \>=2 years)
* Currently consuming a low-carbohydrate (\< 130 g/day) or KD or done so in the last 6-months
* Patients currently participating in an interventional or therapeutic clinical trial involving the use of active anti-cancer therapy.
* Active autoimmune diseases requiring active Immune suppressive medications
* Systemic steroid therapy, excluding for replacement due to adrenal insufficiency
* Major surgery within last 3 months
* BMI \<18 or \>35
* Medical contraindications to the intervention diet as determined by the treating physician.
* Self-reported major dietary restrictions related to the intervention such as irritable bowel syndrome (IBS).
* Patients with a history or active eating disorder
* Uncontrolled Diabetes mellitus or patients receiving insulin
* Known diagnosis of HIV
* Known active hepatitis B or hepatitis C
* Known inborn errors of lipid metabolism
* Sever or uncontrolled Hyperlipidemia (total cholesterol over 400 mg / dL, low-density lipoprotein (LDL) above 300 mg / dL, triglycerides over 500 mg / dl.).
