Combining a ketogenic diet with cognitive training for blood cancer survivors
A Multi-component Non-pharmacological Intervention to Improve Cognitive Outcomes in Hematologic Cancer Survivors
This study is testing if a special diet combined with online brain training can help blood cancer survivors think better over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05708716 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who have been diagnosed with a hematologic malignancy and are experiencing mild to moderate cognitive impairment.
Not a fit: Patients with pre-existing neurological disorders, significant sensory impairments, or those who have participated in similar interventions recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance cognitive functioning in survivors of blood cancers, potentially improving their quality of life.
How similar studies have performed: While the combination of dietary interventions and cognitive training is innovative, similar approaches have shown promise in other populations, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.