← Back to Search

Diet and Cognitive Training for Blood Cancer Survivors

N/A
Recruiting
Led By Noha M Sharafeldin, MD, MSc, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult with hematologic malignancy diagnosed at age ≥21 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks for the multicomponent active arm and from 12 weeks to 24 weeks for the waitlist arm
Awards & highlights

Study Summary

This trial is testing if a diet supplement and online cognitive training can improve cognitive functioning in blood cancer survivors.

Who is the study for?
Adult blood cancer survivors with mild-to-moderate cognitive issues can join. They must be at least 3 months post-transplant or 6 months from diagnosis if no transplant was done, have internet access, and read/write English fluently. Excluded are those with neurological disorders, major psychiatric conditions, severe sensory/motor impairments, active GvHD after a transplant, very low BMI, allergies to soy/milk, recent neuropsychological intervention history or metabolic diseases.Check my eligibility
What is being tested?
The trial is testing whether a special diet (modified ketogenic) plus brain exercises online can help improve thinking skills in blood cancer survivors better than just waiting for treatment. Participants will use the diet supplement and do brain training for 12 weeks while their progress is compared to others who wait before starting the program.See study design
What are the potential side effects?
Potential side effects aren't detailed here but could include typical reactions to dietary changes such as digestive discomfort or changes in energy levels due to the modified ketogenic diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with a blood cancer as an adult.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks for the multicomponent active arm and from 12 weeks to 24 weeks for the waitlist arm
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks for the multicomponent active arm and from 12 weeks to 24 weeks for the waitlist arm for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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)
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
Secondary outcome measures
Change in cognitive function global deficit score (GDS) from 12 wks to 24 wks in patients on the multicomponent active arm
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)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Diet and Cognitive TrainingExperimental Treatment2 Interventions
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.
Group II: WaitList ControlActive Control1 Intervention
The arm will only use the online cognitive training program Lumosity 3 months after enrollment in the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Online cognitive training
2013
N/A
~60

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,571 Previous Clinical Trials
2,269,331 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,261 Total Patients Enrolled
Noha M Sharafeldin, MD, MSc, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Modified ketogenic diet using an exogenous ketogenic formula Clinical Trial Eligibility Overview. Trial Name: NCT05708716 — N/A
Cognitive Impairment Research Study Groups: Diet and Cognitive Training, WaitList Control
Cognitive Impairment Clinical Trial 2023: Modified ketogenic diet using an exogenous ketogenic formula Highlights & Side Effects. Trial Name: NCT05708716 — N/A
Modified ketogenic diet using an exogenous ketogenic formula 2023 Treatment Timeline for Medical Study. Trial Name: NCT05708716 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any opportunities to join this research endeavor?

"Affirmative. According to information sourced from clinicaltrials.gov, this trial is actively seeking participants with 80 people required from a single site. The experiment was first posted on November 22nd 2022 and has been recently updated as of January 31st 2023."

Answered by AI

How many participants have been selected for this medical trial?

"Affirmative. The information on clinicaltrials.gov demonstrate that this medical trial, which was initially made available in November 2022, is actively seeking volunteers. Currently, 80 patients are required from a single site for the study to meet its recruitment goals."

Answered by AI
~36 spots leftby Apr 2025