Combining a ketogenic diet with cognitive training for blood cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the feasibility of a combined intervention program that includes a modified ketogenic diet and online cognitive training for survivors of hematologic malignancies. Participants will be randomized into two groups: one receiving the combined intervention for 12 weeks and a waitlist control group that will start the cognitive training after the wait period. The study will assess whether this intervention improves cognitive functioning compared to the control group and how long any effects may last. Safety and tolerability will be monitored throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting

Study contacts

• Principal investigator: Noha M Sharafeldin, MD, MSc, PhD — University of Alabama at Birmingham
• Study coordinator: Noha M Sharafeldin, MD, MSc, PhD
• Email: nsharafeldin@uabmc.edu
• Phone: 2056382144

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.