Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 8:45 AM
Study NCT ID:
NCT04231734
Status:
WITHDRAWN
Last Update Posted:
2023-08-28
First Post:
2019-12-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketogenic Diet in Patients With Untreated Low Tumor Burden Mantle Cell Lymphoma
Sponsor:
Weill Medical College of Cornell University
Organization:
Study Overview
Official Title:
Pilot Phase I Study of Ketogenic Diet in the Treatment of Patients With Untreated Mantle Cell Lymphoma With a Low Tumor Burden
Status:
WITHDRAWN
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: