Phase I Study of the Safety and Feasibility of a Ketogenic Dietary Intervention to Improve Response to Immunotherapy

Summary

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.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Other
  Best Practice

  Undergo standard of care diet

• Procedure
  Biospecimen Collection

  Undergo blood and stool sample collection

• Procedure
  Computed Tomography

  Under CT

• Other
  Dietary Intervention

  Undergo ketogenic diet

• Other
  Educational Activity

  Receive coaching support

• Other
  Glucose Measurement

  Undergo blood glucose testing

• Other
  Ketone Measurement

Location