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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
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 weeks for the multicomponent active arm and from 12 weeks to 24 weeks for the waitlist arm
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
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
1,593 Previous Clinical Trials
2,282,602 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,703 Previous Clinical Trials
40,931,670 Total Patients Enrolled
Noha M Sharafeldin, MD, MSc, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I finished my bone marrow transplant over 3 months ago or was diagnosed over 6 months ago without a transplant.I am experiencing ongoing symptoms from a transplant rejection.I was diagnosed with a blood cancer as an adult.I have major hearing, sight, or movement issues.
Research Study Groups:
This trial has the following groups:- Group 1: Diet and Cognitive Training
- Group 2: WaitList Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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