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

Clinical Trial Details

In a subset of patients with mantle cell lymphoma (MCL), including those with low tumor burden and slow tumor growth, a period of deferred therapy does not compromise patient outcomes. This period between diagnosis and initiation of treatment may provide an opportunity to evaluate new approaches to the management of lymphoma. 

The ketogenic diet is intended to lower systemic insulin levels. Several lab studies have shown that lowering insulin levels may have an anti-tumor effect.

The purpose of this study is to determine the feasibility of adherence to a 3-month ketogenic diet in patients with low tumor burden mantle cell lymphoma. The study is intended only for patients with mantle cell lymphoma who do not yet need treatment. Analysis of blood samples collected throughout the study may provide additional insights into novel treatment strategies. 

If an individual agrees to participate in this study, data (i.e. date of birth, gender, recent medical history, liver disease history, procedure-related information, hospitalization) will be collected from any visits the participant makes/made to the clinic during their participation for 3 months and followed up for 28 days after the completion of the ketogenic diet. 

Eligibile patients will receive the study treatment, which will consist of the daily ketogenic diet, for up to 12 weeks. The meals for the week are dispensed at each weekly visit. Individuals will be required to keep a food diary to track dietary intake. 

Key Eligibility: 

This study is intended only for patients with mantle cell lymphoma who do not yet need treatment. 

  • Age 18 or older with a histologically confirmed diagnosis of mantle cell lymphoma 
  • Have had no prior systemic therapy for lymphoma 
  • Have a performance status 0, 1, or 2 on the ECOG performance scale

Detailed eligibility will be reviewed when you contact the study team. 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Amelyn Rodriguez, RN
(212) 746-1362
amr2017@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1905020213

ClinicalTrials.gov:

NCT04231734

Status

Open to Enrollment

Age Group

Adult

Sponsor