Ketogenic Diet for Skin and Kidney Cancers
Trial Summary
What is the purpose of this trial?
This phase I trial studies how well a ketogenic dietary intervention works to improve response to immunotherapy in patients with melanoma and kidney cancer that has spread from where it first started (primary site) to other places in the body (metastatic). A ketogenic diet (KD) means eating fewer carbohydrates and more fats. The purpose is to use ketones (normal breakdown from fat) instead of glucose (sugar) as an energy source. Researchers want to see whether a ketogenic diet can improve tumor response in patients receiving immune checkpoint inhibitors (ICI). ICI are newer treatment options that help the immune system better fight some cancers. Following a KD may improve tumor response in patients with metastatic melanoma and metastatic kidney cancer treated with ICI.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it does require that you follow a ketogenic diet and be on specific immunotherapy treatments for melanoma or kidney cancer.
What data supports the effectiveness of the ketogenic dietary intervention treatment for skin and kidney cancers?
Some studies suggest that a ketogenic diet, which is low in carbohydrates and high in fats, may slow the growth of certain tumors, like melanoma, in animal models. However, other research indicates that while it might slow tumor growth, it could also worsen overall survival or promote tumor growth in specific conditions, such as renal tumors in a rat model.12345
Is the ketogenic diet generally safe for humans?
Research shows that the ketogenic diet is generally safe for humans, with studies in breast cancer patients and older adults reporting no severe side effects, though some experienced issues like dyslipidemia (abnormal blood lipid levels) and constipation. However, a study in rats suggested potential risks for kidney tumor growth with long-term use.14678
How does the ketogenic diet treatment differ from other treatments for skin and kidney cancers?
The ketogenic diet is unique because it is a high-fat, low-carbohydrate diet that aims to alter the body's metabolism to slow tumor growth. Unlike traditional cancer treatments like chemotherapy or radiation, which directly target cancer cells, the ketogenic diet seeks to exploit the energy needs of cancer cells, although it may not be suitable for all patients due to potential side effects like weight loss and liver inflammation.12349
Research Team
Marium Husain, MD, MPH
Principal Investigator
Ohio State University Comprehensive Cancer Center
Eligibility Criteria
This trial is for patients with metastatic melanoma or kidney cancer. Participants should be eligible for immunotherapy and willing to follow a ketogenic diet, which means eating fewer carbs and more fats.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a ketogenic dietary intervention with personalized coaching and continuous ketone monitoring over 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and adherence
Treatment Details
Interventions
- Ketogenic Dietary Intervention (Behavioural Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor