Diet and Cognitive Training in Hematologic Cancer Survivors
NCT ID: NCT05708716
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2022-11-22
2027-04-30
Brief Summary
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* is it feasible to combine a ketogenic diet supplementation and online cognitive training in an intervention program
* will patients using the combined intervention program have improved cognitive functioning compared to those who don't use it
* how long will the intervention programs effects last
Participants randomized to the intervention arm will consume an exogenous ketogenic supplementation and use an online cognitive training program for 12 weeks, while waitlist arm functions as a control group and will receive the online cognitive training only after a wait period of 12 weeks. Researchers will compare the intervention and waitlist control groups to see if the intervention improves cognitive functioning.
Detailed Description
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A ketogenic diet is characterized by high fat, moderate protein and very low carbohydrate intake. Participants will follow a modified ketogenic diet consuming exogenous Ketocal tetrapaks daily to substitute \~700 calories of their daily calorie needs and limit their carbohydrate intake while maintaining an eucaloric diet. The KetoCal is a nutritionally complete, ready-to-feed ketogenic meal replacement product. The study goal is to achieve safe and tolerable levels of mild nutritional ketosis (0.5-2mmol/L betahydroxybutyrate (BHB) blood concentration). Diet education will be provided to participants on how and when to consume the KetoCal formula, foods and beverages consistent with a ketogenic diet and foods and beverages to avoid, and how to measure the ketosis using a breathalyzer daily. Safety and Tolerability monitoring will occur by recording treatment-emergent and/or treatment-related adverse events, regular monitoring of weight and satiety levels, and routine laboratory testing using fasting blood samples at baseline and 12 weeks.
The Lumosity program offers over 60 tasks in game-like format that cover the main cognitive domains: processing speed, working memory, attention and executive function. Training will involve a daily session of 5 training tasks for 12 weeks. Each time the patient is logged in for a session, a customized report will be generated by the Lumosity program to capture performance information.
Participants' cognitive functioning will be assessed at baseline and 12 weeks using objectively measured cognitive function to estimate the preliminary efficacy of intervention program; and at 24 weeks to examine the sustained effects of the multi-component intervention program.
The findings from this project will inform a definitive phase III trial of a multi-component intervention to improve cognitive outcomes in patients with hematologic malignancy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Diet and Cognitive Training
The arm will follow a modified ketogenic diet using an exogenous ketogenic formula (KetoCal) and use the online cognitive training program Lumosity at time of enrollment on the study.
Modified ketogenic diet using an exogenous ketogenic formula
Participants will follow a modified ketogenic diet consuming a daily exogenous ketogenic meal replacement formula while limiting their carbohydrate intake for 12 weeks.
Online cognitive training
Participants will complete a daily session of 5 online cognitive training tasks for 12 weeks.
WaitList Control
The arm will only use the online cognitive training program Lumosity 3 months after enrollment in the study.
Online cognitive training
Participants will complete a daily session of 5 online cognitive training tasks for 12 weeks.
Interventions
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Modified ketogenic diet using an exogenous ketogenic formula
Participants will follow a modified ketogenic diet consuming a daily exogenous ketogenic meal replacement formula while limiting their carbohydrate intake for 12 weeks.
Online cognitive training
Participants will complete a daily session of 5 online cognitive training tasks for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Outpatient at least 3 months from completion of blood or marrow transplant (BMT) or at least 6 months from diagnosis for patients not treated with BMT
* Evidence of mild-to-moderate cognitive impairment using either the Modified Telephone Interview for Mild Cognitive Impairment (TICS-M) or PROMIS 8a short form raw score = 19 -37
* Have daily access to an internet-connected home computer
* Can fluently read and write in English
* Can understand and sign the study-specific Informed Consent Form
Exclusion Criteria
* Significant auditory, visual, or motor impairments
* History of color blindness
* Participated in neuropsychological intervention within the past 6 months
* Evidence of active chronic graft vs. host disease (GvHD) for allogeneic BMT
* History of pre-existing metabolic disease
* Allergies to soy or milk
* Body Mass Index (BMI) ≤20
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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Noha Mohamed Sharafeldin
Assistant Professor
Principal Investigators
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Noha M Sharafeldin, MD, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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161221006
Identifier Type: -
Identifier Source: org_study_id