NCT04231734

Ketogenic Diet in Patients With Untreated Low Tumor Burden Mantle Cell Lymphoma

Pilot Phase I Study of Ketogenic Diet in the Treatment of Patients With Untreated Mantle Cell Lymphoma With a Low Tumor Burden

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates adherence to a ketogenic diet in patients with low tumor burden, treatment-naïve mantle cell lymphoma.

Detailed description

This is a single-arm feasibility study to evaluate adherence to a ketogenic diet in patients with low tumor burden, treatment-naïve mantle cell lymphoma. Subjects will be evaluated for eligibility and baseline assessments prior to initiating the ketogenic diet during the screening period and/or prior to initiating the ketogenic diet on Day 1. Eligible subjects will receive study treatment which will consist of a daily ketogenic diet for up to 12 weeks (Day 1 through Day 84). Subjects will be monitored with weekly assessments of adherence to diet and effects on serum metabolic markers, tumor specimens, and body composition. After discontinuing the ketogenic diet, subjects will be followed for 28 days.

Conditions

• Mantle Cell Lymphoma
• Ketogenic Dieting

Interventions

Type	Name	Description
OTHER	Ketogenic Diet	Prepared ketogenic meals, 3 per day for up to 12 weeks (Day 1 through Day 84)

Timeline

• Start date: 2023-04-01
• Primary completion: 2026-04-01
• Completion: 2026-09-01
• First posted: 2020-01-18
• Last updated: 2023-08-28

Locations

1 site across 1 country: United States