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Ketogenic Diet for Skin and Kidney Cancers

N/A

Waitlist Available

Led By Marium Husain, MD, MPH

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with confirmed diagnosis of metastatic melanoma receiving first line treatment with specified medications

Patients with confirmed diagnosis of metastatic renal cell carcinoma receiving first line treatment with specified medications

Must not have

Individuals < 18 years of age

Patients who are clinically underweight (BMI < 18.5) at the start of treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if following a ketogenic diet, which involves eating fewer carbohydrates and more fats, can improve the response to immunotherapy in patients with metastatic melanoma and kidney cancer. The idea

Who is the study for?

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.

What is being tested?

The study tests if a ketogenic diet can boost the effectiveness of immune checkpoint inhibitors (a type of immunotherapy) in treating metastatic melanoma and kidney cancer.

What are the potential side effects?

Potential side effects may include those associated with a strict ketogenic diet, such as fatigue, headache, dizziness, nutrient deficiencies, and gastrointestinal discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have metastatic melanoma and am on my first treatment.

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I have metastatic renal cell carcinoma and am on my first treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I am underweight with a BMI below 18.5.

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I am not currently in a cancer treatment study.

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I have diabetes and use insulin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence (feasibility measure)

Incidence of adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (Ketogenic diet)Experimental Treatment7 Interventions

Patients undergo a ketogenic dietary intervention with personalized coaching from a dietician about the KD, which includes extensive educational and ongoing support on the KD and continuous ketone monitoring by talking to a dietician directly, with the ability to text a dietician at any time and expect a response within 12 hours over 24weeks. Patients also undergo daily blood glucose and ketone monitoring, undergo CT, undergo blood sample collection and may undergo stool sample collection on the study.

Group II: Arm II (usual caare)Active Control1 Intervention

Patients follow a standard of care diet on the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Computed Tomography

2017