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NCT05708716
Diet and Cognitive Training in Hematologic Cancer Survivors
Conditions: Cognitive Impairment, Hematologic Malignancy
Sex: All
Ages: 21 Years – N/A
Phase: NA
Enrollment: 80
Sponsor: University of Alabama at Birmingham
Location: United States
Summary
The goal of this clinical trial is to examine feasibility of a cognitive intervention program in blood cancer survivors.
The main questions it aims to answer are:is it feasible to combine a ketogenic diet supplementation and online cognitive training in an intervention programwill patients using the combined intervention program have improved cognitive functioning compared to those who don't use ithow long will the intervention programs effects lastParticipants 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.
Eligibility Criteria
Inclusion Criteria:Adult with hematologic malignancy diagnosed at age ≥21 yearsOutpatient at least 3 months from completion of blood or marrow transplant (BMT) or at least 6 months from diagnosis for patients not treated with BMTEvidence 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 -37Have daily access to an internet-connected home computerCan fluently read and write in EnglishCan understand and sign the study-specific Informed Consent FormExclusion Criteria:History of pre-existing neurological disorder or documented major psychiatric disorderSignificant auditory, visual, or motor impairmentsHistory of color blindnessParticipated in neuropsychological intervention within the past 6 monthsEvidence of active chronic graft vs. host disease (GvHD) for allogeneic BMTHistory of pre-existing metabolic diseaseAllergies to soy or milkBody Mass Index (BMI) ≤20
Source: ClinicalTrials.gov (NCT05708716). StuddyBuddy aggregates publicly available trial information.