This clinical trial aims to evaluate whether a ketogenic diet (KD), when combined with immunotherapy, can improve immune function and treatment outcomes in patients with advanced melanoma, cutaneous squamous cell carcinoma (cSCC), or renal cell carcinoma (RCC).
Why Is This Study Important? Immunotherapy is a promising cancer treatment, but not all patients respond well. Research suggests that diet, particularly a high-fat, low-carbohydrate ketogenic diet, may help boost the immune system and make treatments more effective.
What Will This Study Examine?
Researchers want to understand:
Is the ketogenic diet well-tolerated for cancer patients? Does the diet improve immune responses and treatment effectiveness?
How Will the Study Work?
Participants will be placed into one of two groups:
Ketogenic Diet (KD) Group: A structured high-fat, low-carb diet (intermittent schedule: 2 weeks on, 1 week off).
Standard Diet (SD) Group: A typical diet with no major changes. Throughout the study, a dietitian will closely support and guide you. Both groups will continue their standard immunotherapy treatment.
What Will Participants Do? Write their food intake three times a week to help assess dietary adherence Follow their assigned diet for 10 weeks Have weekly check-ins with a dietitian (in-person at the hospital or via phone) Have weekly blood glucose and ketone level checks using a home device. Provide monthly blood samples to measure immune response during routine immunotherapy infusions Provide stool samples for gut microbiome analysis at the start and end of the study Measure Monthly Weight, body composition, and resting calorie burn Complete quality-of-life questionnaires
What Are the Potential Benefits? Improved response to immunotherapy Better understanding of how diet influences cancer treatment Potential for a new supportive strategy for cancer care
This study may help uncover ways to enhance cancer treatment through personalized nutrition.
• Males and females, age >= 18 years
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
• 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
Sequential
Ketogenic diet
Dietary supplementKetogenic Diet as an Adjunct to Immunotherapy: Unlike many trials focused on chemotherapy or targeted therapies, this study specifically investigates the synergistic effects of the ketogenic diet with immune checkpoint inhibitors (ICIs), a promising approach for enhancing immunotherapy efficacy. The diet's high-fat, low-carbohydrate regimen is designed to shift metabolism towards ketone bodies and fatty acid utilization, potentially modulating immune responses and tumor immunogenicity in a way that standard diets do not.
Number of Participants Adhering to the Ketogenic Diet and Experiencing Treatment-Related Adverse Events as Assessed by CTCAE v5.0
This measure will assess the feasibility and tolerability of the ketogenic diet (KD) in cancer patients undergoing immunotherapy by evaluating: Diet Adherence: The number of participants who maintain KD for at least 80% of the study duration, based on dietary intake logs and ketone level measurements. Tolerability: The number of participants experiencing treatment-related adverse events (AEs), as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The severity and frequency of AEs will be documented and categorized.
Change in Peripheral Blood Mononuclear Cell (PBMC) Composition at Baseline, During, and Post-Intervention
This measure will evaluate changes in immune cell composition in response to the ketogenic diet (KD) and immunotherapy. PBMC Composition: Assessed using cytometry by time-of-flight (CyTOF) to characterize shifts in immune cell subsets (e.g., T cells, natural killer cells, monocytes). Data Analysis: Changes from the baseline will be reported as absolute values and fold-changes over time.
Serum Cytokine Levels at Baseline, During, and Post-Intervention
This measure will evaluate changes in cytokine levels in response to the ketogenic diet (KD) and immunotherapy. Serum Cytokine Levels: Quantified using multiplex immunoassays to measure the concentrations of key cytokines, such as IL-2, IFN-γ, TNF-α, and IL-10. Data Analysis: Changes from baseline will be reported as absolute values and fold-changes over time.
Overall response rate according to RECIST v1.
Adherence to Dietary Interventions - Ketone Level Measurements
Ketone Level Measurements: Ketone levels will be measured to assess whether participants are in a state of ketosis (\>0.3 Mm), indicating adherence to the ketogenic diet. Data Analysis: Ketone levels will be analyzed to determine adherence to the ketogenic diet.
Change in Body Weight (kg) Over the Study Period
Body weight (in kilograms) will be measured using a calibrated digital scale at specified time points. Changes from baseline will be reported as absolute weight differences and percentage change
Change in Quality of Life Score Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Quality of life will be assessed using the EORTC QLQ-C30 questionnaire, a validated tool for measuring cancer patients' health-related quality of life. The EORTC QLQ-C30 consists of 30 items, evaluating functional scales (physical, role, emotional, cognitive, and social functions), symptom scales (fatigue, pain, nausea/vomiting, etc.), and global health status. Scores range from 0 to 100. Higher scores on functional and global health scales indicate better quality of life. Higher scores on symptom scales indicate greater symptom burden (worse outcome). Changes from baseline to Week 10 will be reported as mean score differences.
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