Spots Global Cancer Trial Database for Ketogenic Diet in Patients With Untreated Low Tumor Burden Mantle Cell Lymphoma

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Trial Identification

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

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

Study ID: NCT04231734

Conditions

Mantle Cell Lymphoma

Ketogenic Dieting

Interventions

Ketogenic Diet

Study Description

Brief 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.