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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04231734
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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

Condition or disease Intervention/treatment Phase
Mantle Cell Lymphoma Ketogenic Dieting Other: Ketogenic Diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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 ]
  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Understand and voluntarily sign an ICF prior to any study related assessments and procedures are conducted

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 1. [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.
  • An ECG recorded at screening showing evidence of cardiac ischemia (ST depression of ≥ 2 mm, measured from isoelectric line to the ST segment). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present.
  • Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions and/or ejection fraction < 40% by multigated acquisition (MUGA) scan or < 50% by echocardiogram and/or magnetic resonance imaging (MRI).
  • Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before the start of study medication.
  • Patients requiring dual anti-platelets treatment for cardiac conditions or patients who are on anticoagulation for arterial or venous thrombosis.
  • Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Type I diabetes
  • Uncontrolled Type II diabetes mellitus (HbA1c> 7.5%).
  • Type II diabetes requiring treatment with a sulfonylurea, meglitinide, or insulin.
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
  • Active complaints of dysphagia or odynophagia
  • Presence of a "feeding tube" (i.e. nasogastric tube, PEG, PEJ)
  • Participation in a specialty diet (e.g. Atkins, Weight Watchers, Best Life, Nutrisystem, South Beach, Jenny Craig, Paleo Diet, Zone, etc) or weight loss plan within 28 days prior to Cycle 1 of treatment.
  • Vegetarian or vegan eating habits.
  • An allergy or intolerance to egg, gluten, tree nuts, or milk protein.
  • History of serious or uncontrolled gout or hyperuricemia
  • Diagnosis of a seizure disorder.
  • Prior diagnosis of restless legs syndrome or a history of chronic muscle cramps, as defined as a period of at least 1 month where spontaneous cramping of the skeletal muscles occurred more than two-thirds of the days.
  • Patients who are pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through at least 30 days after the last dose of trial treatment.
  • History of nephrolithiasis or nephrolithiasis incidentally discovered during CT screening.
  • Known selenium deficiency.

Information from the National Library of Medicine

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


Contacts
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Contact: Amelyn Rodriguez, R.N. 212-746-1362 amr2017@med.cornell.edu
Contact: Christine Tran, R.N. 212-746-6738 cht2328@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine
New York, New York, United States, 10065
Contact: Amelyn Rodriguez, R.N.    212-746-1362    amr2017@med.cornell.edu   
Contact: Christine Tran, R.N.    212-746-6738    cht2328@med.cornell.edu   
Principal Investigator: Peter Martin, M.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Peter Martin, M.D. Weill Cornell Medicine

Additional Information:
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04231734    
Other Study ID Numbers: 19-05020213
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin