NCT05708716

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Nov 2022Apr 2027

Study Start

First participant enrolled

November 22, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

4.1 years

First QC Date

January 11, 2023

Last Update Submit

December 12, 2025

Conditions

Cognitive ImpairmentHematologic Malignancy

Keywords

Hematologic Cancer SurvivorsBlood or Marrow TransplantationCognitive TrainingModified Ketogenic Diet

Outcome Measures

Primary Outcomes (2)

  • Number of hematologic malignancy patients completing the 2-arm 12wk randomized wait-listed trial of the multicomponent intervention of modified ketogenic diet and cognitive training

    Number of participants completing the 12 week intervention

    12 weeks

  • Change in cognitive function global deficit score (GDS) from baseline to 12 wks, comparing patients on the multicomponent active arm to the waitlist arm (prior to receiving cognitive training)

    Change in cognitive function will be measured using the cognitive function global deficit score (GDS) at baseline and 12 weeks comparing both active and waitlist arms. The neuropsychological test battery will include the following tests: D-KEFS Verbal Fluency, DKEFS Color-Word Interference, D-KEFS Trail Making, WAIS-IV Digit-Symbol Coding, WAIS-IV Digit Span, WAIS-IV Letter-Number Sequencing, WMS-IV Logical Memory, CVLT-II). Raw scores from the neuropsychological test battery will be transformed to standardized T-scores (mean=50; SD=10) using published normative data. T-scores will be converted to a deficit score ranging from 0 (no impairment) to 5 (severe impairment) and averaged across all tests to calculate the GDS. A lower GDS score means better cognitive function.

    Baseline to 12 weeks

Secondary Outcomes (2)

  • Change in cognitive function global deficit score (GDS) from baseline to 12 wks in patients on the multicomponent active arm compared to change in cognition from 12 wks to 24 wks in patients on the waitlist arm (following receiving cognitive training)

    Baseline to 12 weeks for the multicomponent active arm and from 12 weeks to 24 weeks for the waitlist arm

  • Change in cognitive function global deficit score (GDS) from 12 wks to 24 wks in patients on the multicomponent active arm

    12 weeks to 24 weeks

Study Arms (2)

Diet and Cognitive Training

EXPERIMENTAL

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.

Behavioral: Modified ketogenic diet using an exogenous ketogenic formulaBehavioral: Online cognitive training

WaitList Control

ACTIVE COMPARATOR

The arm will only use the online cognitive training program Lumosity 3 months after enrollment in the study.

Behavioral: Online cognitive training

Interventions

Modified ketogenic diet using an exogenous ketogenic formulaBEHAVIORAL

Participants will follow a modified ketogenic diet consuming a daily exogenous ketogenic meal replacement formula while limiting their carbohydrate intake for 12 weeks.

Also known as: KetoCal
Diet and Cognitive Training
Online cognitive trainingBEHAVIORAL

Participants will complete a daily session of 5 online cognitive training tasks for 12 weeks.

Also known as: Lumosity
Diet and Cognitive TrainingWaitList Control

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult with hematologic malignancy diagnosed at age ≥21 years
  • 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

You may not qualify if:

  • History of pre-existing neurological disorder or documented major psychiatric disorder
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Cognitive DysfunctionHematologic Neoplasms

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Noha M Sharafeldin, MD, MSc, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noha M Sharafeldin, MD, MSc, PhD

CONTACT

2056382144nsharafeldin@uabmc.edu

Lindsey Hageman, MPH

CONTACT

2056382139lihageman@uabmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 11, 2023

First Posted

February 1, 2023

Study Start

November 22, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

April 30, 2027

Last Updated

December 17, 2025

Record last verified: 2025-12

Locations

US(1)