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

Weill Medical College of Cornell University1 site in 1 countryApril 2023

ConditionsMantle Cell Lymphoma Ketogenic Dieting

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mantle Cell Lymphoma
Sponsor: Weill Medical College of Cornell University
Locations: 1
Primary Endpoint: Number of subjects who adhere to ketogenic diet
Status: Withdrawn
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2023

End Date

September 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Weill Medical College of Cornell University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed diagnosis of mantle cell lymphoma
•Age ≥ 18 years
•No prior systemic therapy for lymphoma
•ECOG performance status ≤ 2
•Required initial laboratory parameters:
•Absolute neutrophil count (ANC) ≥ 1000 cells/mm3
•Platelet count ≥ 75,000 cells/mm3
•Calculated creatinine clearance ≥ 30 ml/min by Cockcroft-Gault formula
•Total bilirubin ≤ 2.0 x ULN
•AST/SGOT or ALT/SGPT ≤ 3.0 x ULN

Exclusion Criteria

•Patients with blastoid histology
•Patients with known or suspected central nervous system (CNS) involvement
•Patients with a clear indication for treatment of lymphoma, including those with a tumor larger than 6 cm, more than 3 lymph nodes more than 3 cm, or constitutional symptoms
•Active viral infection with HIV or hepatitis type B or C. Seropositive HBV patients are eligible if they are negative for HBV DNA by PCR and receive concomitant antiviral therapy during treatment and for additional six months after coming off study.
•Active uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment)
•Uncontrolled moderate to severe hypertriglyceridemia (TG\>300 mg/dL).
•Strong family history of hypertriglyceridemia and coronary artery disease.
•Myocardial infarction within 6 months of cycle 1, day
•\[Subjects with a history of myocardial infarction between 6 and 12 months prior to cycle 1, day 1, who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event, may participate\].
•Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV. In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present.

Outcomes

Primary Outcomes

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

Secondary Outcomes

Effect of ketogenic diet on gut microbiome(12 weeks)
Rate of recruitment(1 year)
Number of subjects who exhibit a significant change in fasting serum metabolic markers(Baseline, 16 weeks)
Number of subjects who exhibit a significant change in serum mediators of inflammation(Baseline, 16 weeks)
Subject adherence to meal assessments(12 weeks)
Rate of attrition(12 weeks)
Number of subjects who exhibit a significant change in blood cell populations(Baseline, 16 weeks)
Rate of daily ketosis(12 weeks)
Number of subjects who achieve a partial or complete response(12 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(Baseline, 16 weeks)
Number of subjects who complete quality of life questionnaires at required timepoints(16 weeks)
Subject adherence to scheduled laboratory assessments(12 weeks)