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Mantle Cell LymphomaNCT04231734

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

A study testing Ketogenic Diet in people with Mantle Cell Lymphoma and Ketogenic Dieting, run by Weill Medical College of Cornell University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study evaluates adherence to a ketogenic diet in patients with low tumor burden, treatment-naïve mantle cell lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma, Ketogenic Dieting
What is being tested?
Ketogenic Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Apr 2023to Sep 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Weill Cornell Medicine

    New York, New York, 10065

Other trials in United States

About this study

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

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

Read the 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.

Being tested
Ketogenic Diet
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ketogenic DietOther

    Prepared ketogenic meals, 3 per day for up to 12 weeks (Day 1 through Day 84)

Study groups in NCT04231734
Study groupRoleWhat they receive
All SubjectsExperimentalLow tumor burden, treatment-naïve MCL
Receives: Other: Ketogenic Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 weeks

Secondary outcomes (12)

  1. 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

    Measured: 12 weeks

  2. 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

    Measured: Baseline, 16 weeks

  3. 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.

    Measured: Baseline, 16 weeks

  4. 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

    Measured: Baseline, 16 weeks

  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

    Measured: Baseline, 16 weeks

  6. 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

    Measured: 16 weeks

  7. Effect of ketogenic diet on gut microbiome

    Change in proportion of most common gut bacteria identified by DNA analysis of stool samples

    Measured: 12 weeks

  8. Rate of recruitment

    Percentage of subjects screened for the trial who eventually enroll in the trial

    Measured: 1 year

  9. Subject adherence to scheduled laboratory assessments

    Percentage of laboratory assessments successfully attended by subjects

    Measured: 12 weeks

  10. Subject adherence to meal assessments

    Percentage of meal assessments successfully completed by subjects

    Measured: 12 weeks

  11. Rate of attrition

    Percentage of subjects enrolled who drop out before trial completion

    Measured: 12 weeks

  12. Rate of daily ketosis

    Percentage of days in ketosis as defined by positive ketones results on ketostix

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study startApr 2023 (estimated)
  3. Primary completionApr 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Why it stopped: Low accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04231734
Sponsor's protocol ID
19-05020213
Status last verified
Aug 2023
First submitted
30 Dec 2019
Last updated
28 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ketogenic Diet in people with Mantle Cell Lymphoma and Ketogenic Dieting, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects who adhere to ketogenic diet (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04231734.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.

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