Ketogenic Diet in Patients With Untreated Low Tumor Burden Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT04231734|
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma Ketogenic Dieting||Other: Ketogenic Diet||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Phase I Study of Ketogenic Diet in the Treatment of Patients With Untreated Mantle Cell Lymphoma With a Low Tumor Burden|
|Estimated Study Start Date :||April 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||June 2022|
Experimental: All Subjects
Low tumor burden, treatment-naïve MCL
Other: Ketogenic Diet
Prepared ketogenic meals, 3 per day for up to 12 weeks (Day 1 through Day 84)
- Number of subjects who adhere to ketogenic diet [ Time Frame: 12 weeks ]Number of subjects who adhere to ketogenic diet as defined by serum betahydroxybutyrate > 1.0 mM at 7 out of 11 timepoints
- Number of subjects who achieve a partial or complete response [ Time Frame: 12 weeks ]Number of subjects who achieve a partial or complete response based on radiographic imaging using Lugano criteria for lymphoma response
- Number of subjects who exhibit a significant change in fasting serum metabolic markers [ Time Frame: Baseline, 16 weeks ]Fasting metabolic markers to be assessed for this outcome measure include insulin, glucose, and lipids
- Number of subjects who exhibit a significant change in serum mediators of inflammation [ Time Frame: Baseline, 16 weeks ]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.
- Number of subjects who exhibit a significant change in blood cell populations [ Time Frame: Baseline, 16 weeks ]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
- 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 ]
- Number of subjects who complete quality of life questionnaires at required timepoints [ Time Frame: 16 weeks ]Quality of life questionnaire to be used for this outcome measure is EORTC-C30
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04231734
|Contact: Amelyn Rodriguez, R.N.||firstname.lastname@example.org|
|Contact: Christine Tran, R.N.||email@example.com|
|United States, New York|
|Weill Cornell Medicine|
|New York, New York, United States, 10065|
|Contact: Amelyn Rodriguez, R.N. 212-746-1362 firstname.lastname@example.org|
|Contact: Christine Tran, R.N. 212-746-6738 email@example.com|
|Principal Investigator: Peter Martin, M.D.|
|Principal Investigator:||Peter Martin, M.D.||Weill Cornell Medicine|