NCT05708716 Diet and Cognitive Training in Hematologic Cancer Survivors
| NCT ID | NCT05708716 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-11-22 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2022-11-22 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Noha M Sharafeldin, MD, MSc, PhD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT05708716 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05708716 currently recruiting?
Yes, NCT05708716 is actively recruiting participants. Contact the research team at nsharafeldin@uabmc.edu for enrollment information.
Where is the NCT05708716 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT05708716 clinical trial?
NCT05708716 is sponsored by University of Alabama at Birmingham. The principal investigator is Noha M Sharafeldin, MD, MSc, PhD at University of Alabama at Birmingham. The trial plans to enroll 80 participants.