This study evaluates adherence to a ketogenic diet in patients with low tumor burden, treatment-naïve mantle cell lymphoma.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Prepared ketogenic meals, 3 per day for up to 12 weeks (Day 1 through Day 84)
Weill Cornell Medicine
New York, New York, United States
Number of subjects who adhere to ketogenic diet
Number of subjects who adhere to ketogenic diet as defined by serum betahydroxybutyrate \> 1.0 mM at 7 out of 11 timepoints
Time frame: 12 weeks
Number of subjects who achieve a partial or complete response
Number of subjects who achieve a partial or complete response based on radiographic imaging using Lugano criteria for lymphoma response
Time frame: 12 weeks
Number of subjects who exhibit a significant change in fasting serum metabolic markers
Fasting metabolic markers to be assessed for this outcome measure include insulin, glucose, and lipids
Time frame: Baseline, 16 weeks
Number of subjects who exhibit a significant change in serum mediators of inflammation
Serum mediators of inflammation to be assessed for this outcome measure include high sensitivity C-reactive protein (hs-CRP), interleukin (IL)-6, tumor necrosis factor (TNF)-a, IL-1beta, and interferon (INF)-gamma.
Time frame: Baseline, 16 weeks
Number of subjects who exhibit a significant change in blood cell populations
Blood cell populations will be assessed by performance of unbiased expression analysis (RNA-Seq) from blood cell populations, and High-Dimensional Single-Cell Mass Cytometry (CyTOF) analysis of peripheral blood cells
Time frame: Baseline, 16 weeks
Change in body composition as measured by difference in ideal body weight and actual body weight at the end of study compared to baseline
Time frame: Baseline, 16 weeks
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Number of subjects who complete quality of life questionnaires at required timepoints
Quality of life questionnaire to be used for this outcome measure is EORTC-C30
Time frame: 16 weeks
Effect of ketogenic diet on gut microbiome
Change in proportion of most common gut bacteria identified by DNA analysis of stool samples
Time frame: 12 weeks
Rate of recruitment
Percentage of subjects screened for the trial who eventually enroll in the trial
Time frame: 1 year
Subject adherence to scheduled laboratory assessments
Percentage of laboratory assessments successfully attended by subjects
Time frame: 12 weeks
Subject adherence to meal assessments
Percentage of meal assessments successfully completed by subjects
Time frame: 12 weeks
Rate of attrition
Percentage of subjects enrolled who drop out before trial completion
Time frame: 12 weeks
Rate of daily ketosis
Percentage of days in ketosis as defined by positive ketones results on ketostix
Time frame: 12 weeks