Diet and Cognitive Training for Blood Cancer Survivors
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of this treatment for blood cancer survivors?
Research shows that computerized cognitive training programs can help improve cognitive symptoms in long-term cancer survivors, and online cognitive therapy has been beneficial for breast cancer survivors. These findings suggest that similar approaches might be helpful for blood cancer survivors as well.12345
Is the ketogenic diet safe for humans?
How is the treatment of a modified ketogenic diet and online cognitive training unique for blood cancer survivors?
This treatment is unique because it combines a modified ketogenic diet, which uses a special formula to increase ketone levels in the body, with online cognitive training to potentially improve cognitive function. Unlike standard treatments, this approach targets both dietary and cognitive aspects, offering a non-drug option for managing cognitive symptoms in blood cancer survivors.12111213
Research Team
Noha Sharafeldin, MD, MSc, PhD
Principal Investigator
University of Alabama at Birmingham
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants in the intervention arm consume an exogenous ketogenic supplementation and use an online cognitive training program for 12 weeks
Waitlist Control
Participants in the waitlist control arm receive the online cognitive training program after a wait period of 12 weeks
Follow-up
Participants are monitored for sustained effects of the intervention program
Treatment Details
Interventions
- Modified ketogenic diet using an exogenous ketogenic formula
- Online cognitive training
Modified ketogenic diet using an exogenous ketogenic formula is already approved in United States, European Union for the following indications:
- Pediatric epilepsy
- Glioblastoma (as part of clinical trials)
- Pediatric epilepsy
- Glioblastoma (as part of clinical trials)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
National Cancer Institute (NCI)
Collaborator