Ketogenic Diet in Patients With Untreated Low Tumor Burden Mantle Cell Lymphoma (NCT04231734) | Clinical Trial Compass
WithdrawnNot Applicable
Ketogenic Diet in Patients With Untreated Low Tumor Burden Mantle Cell Lymphoma
Stopped: Low accrual
United States0Started 2023-04
Plain-language summary
This study evaluates adherence to a ketogenic diet in patients with low tumor burden, treatment-naïve mantle cell lymphoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Myocardi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was listed as 'withdrawn' — can you help me find out why it was withdrawn and whether a similar study looking at ketogenic diet for mantle cell lymphoma is currently running anywhere else?
2Since this study was focused on patients with low tumor burden mantle cell lymphoma who hadn't yet started treatment, does that description fit my situation, and would a dietary approach like this even be worth exploring given where my disease stands right now?
3The main thing this study was measuring was whether people could actually stick to a ketogenic diet — not whether it shrank tumors — so what do we currently know, if anything, about whether diet changes like this might actually affect mantle cell lymphoma outcomes?
4Given that this trial was withdrawn before completing, would you recommend I focus on standard treatment options first, and are there any active clinical trials for my stage of mantle cell lymphoma that might be a better fit for me right now?
5If I were interested in trying a ketogenic diet alongside whatever treatment we decide on, is that something you'd be comfortable helping me manage safely, and are there any risks specific to mantle cell lymphoma patients I should know about?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of subjects who adhere to ketogenic diet
Timeframe: 12 weeks
Trial details
NCT IDNCT04231734
SponsorWeill Medical College of Cornell University