Cognitive ImpairmentNCT05708716
Diet and Cognitive Training in Hematologic Cancer Survivors
A study testing Modified ketogenic diet using an exogenous ketogenic formula and Online cognitive training in people with Cognitive Impairment and Hematologic Malignancy, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cognitive Impairment, Hematologic Malignancy
- What is being tested?
- Modified ketogenic diet using an exogenous ketogenic formula and Online cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2022to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Noha Sharafeldin, MD, MSc, PhD, 2056382144, nsharafeldin@uabmc.edu
Lindsey Hageman, MPH, CCRP, 2056382139, lihageman@uabmc.edu
About this study
Official title: A Multi-component Non-pharmacological Intervention to Improve Cognitive Outcomes in Hematologic Cancer Survivors
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.
Read the detailed description
The investigators propose using "off-the-shelf" products in a 12-week multicomponent cognitive intervention program to address the cognitive impairment in outpatient hematologic malignancy survivors. The program includes two components: i) A modified ketogenic diet using an exogenous ketogenic supplementation using the KetoCal product ([https://shop.myketocal.com/product/ketocal-41-lq]) and ii) online cognitive training using Lumosity program (http://www.lumosity.com/).
A ketogenic diet is characterized by high fat, moderate protein and very low carbohydrate intake. Participants will follow a modified ketogenic diet consuming exogenous Ketocal tetrapaks daily to substitute ~700 calories of their daily calorie needs and limit their carbohydrate intake while maintaining an eucaloric diet. The KetoCal is a nutritionally complete, ready-to-feed ketogenic meal replacement product. The study goal is to achieve safe and tolerable levels of mild nutritional ketosis (0.5-2mmol/L betahydroxybutyrate (BHB) blood concentration). Diet education will be provided to participants on how and when to consume the KetoCal formula, foods and beverages consistent with a ketogenic diet and foods and beverages to avoid, and how to measure the ketosis using a breathalyzer daily. Safety and Tolerability monitoring will occur by recording treatment-emergent and/or treatment-related adverse events, regular monitoring of weight and satiety levels, and routine laboratory testing using fasting blood samples at baseline and 12 weeks.
The Lumosity program offers over 60 tasks in game-like format that cover the main cognitive domains: processing speed, working memory, attention and executive function. Training will involve a daily session of 5 training tasks for 12 weeks. Each time the patient is logged in for a session, a customized report will be generated by the Lumosity program to capture performance information.
Participants' cognitive functioning will be assessed at baseline and 12 weeks using objectively measured cognitive function to estimate the preliminary efficacy of intervention program; and at 24 weeks to examine the sustained effects of the multi-component intervention program.
The findings from this project will inform a definitive phase III trial of a multi-component intervention to improve cognitive outcomes in patients with hematologic malignancy.
- Conditions
- Cognitive Impairment, Hematologic Malignancy
- Being tested
- Modified ketogenic diet using an exogenous ketogenic formula, Online cognitive training
- Keywords
- Hematologic Cancer Survivors, Blood or Marrow Transplantation, Cognitive Training, Modified Ketogenic Diet
- Medical subject headings
- Cognitive Dysfunction, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified ketogenic diet using an exogenous ketogenic formulaBehavioural
Also called KetoCal
Participants will follow a modified ketogenic diet consuming a daily exogenous ketogenic meal replacement formula while limiting their carbohydrate intake for 12 weeks.
Online cognitive trainingBehavioural
Also called Lumosity
Participants will complete a daily session of 5 online cognitive training tasks for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Diet and Cognitive Training | Experimental | 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. Receives: Behavioral: Modified ketogenic diet using an exogenous ketogenic formula; Behavioral: Online cognitive training |
| WaitList Control | Active comparator | The arm will only use the online cognitive training program Lumosity 3 months after enrollment in the study. Receives: Behavioral: Online cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Number of participants completing the 12 week intervention
Measured: 12 weeks
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)
Change in cognitive function will be measured using the cognitive function global deficit score (GDS) at baseline and 12 weeks comparing both active and waitlist arms. The neuropsychological test battery will include the following tests: D-KEFS Verbal Fluency, DKEFS Color-Word Interference, D-KEFS Trail Making, WAIS-IV Digit-Symbol Coding, WAIS-IV Digit Span, WAIS-IV Letter-Number Sequencing, WMS-IV Logical Memory, CVLT-II). Raw scores from the neuropsychological test battery will be transformed to standardized T-scores (mean=50; SD=10) using published normative data. T-scores will be converted to a deficit score ranging from 0 (no impairment) to 5 (severe impairment) and averaged across all tests to calculate the GDS. A lower GDS score means better cognitive function.
Measured: Baseline to 12 weeks
Secondary outcomes (2)
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)
Change in cognitive function will be measured using cognitive function global deficit score (GDS) at baseline and 12 weeks on the multicomponent active arm and 12 weeks to 24 weeks on the waitlist arm following receiving the cognitive training only. The neuropsychological test battery will include the following tests: D-KEFS Verbal Fluency, DKEFS Color-Word Interference, D-KEFS Trail Making, WAIS-IV Digit-Symbol Coding, WAIS-IV Digit Span, WAIS-IV Letter-Number Sequencing, WMS-IV Logical Memory, CVLT-II). Raw scores from the neuropsychological test battery will be transformed to standardized T-scores (mean=50; SD=10) using published normative data. T-scores will be converted to a deficit score ranging from 0 (no impairment) to 5 (severe impairment) and averaged across all tests to calculate the GDS. A lower GDS score means better cognitive function.
Measured: Baseline to 12 weeks for the multicomponent active arm and from 12 weeks to 24 weeks for the waitlist arm
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 will be measured using cognitive function global deficit score (GDS) at 12 weeks to 24 weeks on the multicomponent active arm. The neuropsychological test battery will include the following tests: D-KEFS Verbal Fluency, DKEFS Color-Word Interference, D-KEFS Trail Making, WAIS-IV Digit-Symbol Coding, WAIS-IV Digit Span, WAIS-IV Letter-Number Sequencing, WMS-IV Logical Memory, CVLT-II). Raw scores from the neuropsychological test battery will be transformed to standardized T-scores (mean=50; SD=10) using published normative data. T-scores will be converted to a deficit score ranging from 0 (no impairment) to 5 (severe impairment) and averaged across all tests to calculate the GDS. A lower GDS score means better cognitive function.
Measured: 12 weeks to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start22 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Noha Mohamed Sharafeldin, University of Alabama at Birmingham
- Investigators
- Noha M Sharafeldin, MD, MSc, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708716
- Sponsor's protocol ID
- 161221006
- Other IDs
- R03CA270671
- Status last verified
- Dec 2025
- First submitted
- 11 Jan 2023
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-component Non-pharmacological Intervention to Improve Cognitive Outcomes in Hematologic Cancer Survivors
- ClinicalTrials.gov ID
- NCT05708716
- Acronym / sponsor ID
- 161221006
- Conditions
- Cognitive Impairment, Hematologic Malignancy
- Keywords
- Hematologic Cancer Survivors, Blood or Marrow Transplantation, Cognitive Training, Modified Ketogenic Diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators propose using "off-the-shelf" products in a 12-week multicomponent cognitive intervention program to address the cognitive impairment in outpatient hematologic malignancy survivors. The program includes two components: i) A modified ketogenic diet using an exogenous ketogenic supplementation using the KetoCal product ([https://shop.myketocal.com/product/ketocal-41-lq]) and ii) online cognitive training using Lumosity program (http://www.lumosity.com/).
A ketogenic diet is characterized by high fat, moderate protein and very low carbohydrate intake. Participants will follow a modified ketogenic diet consuming exogenous Ketocal tetrapaks daily to substitute ~700 calories of their daily calorie needs and limit their carbohydrate intake while maintaining an eucaloric diet. The KetoCal is a nutritionally complete, ready-to-feed ketogenic meal replacement product. The study goal is to achieve safe and tolerable levels of mild nutritional ketosis (0.5-2mmol/L betahydroxybutyrate (BHB) blood concentration). Diet education will be provided to participants on how and when to consume the KetoCal formula, foods and beverages consistent with a ketogenic diet and foods and beverages to avoid, and how to measure the ketosis using a breathalyzer daily. Safety and Tolerability monitoring will occur by recording treatment-emergent and/or treatment-related adverse events, regular monitoring of weight and satiety levels, and routine laboratory testing using fasting blood samples at baseline and 12 weeks.
The Lumosity program offers over 60 tasks in game-like format that cover the main cognitive domains: processing speed, working memory, attention and executive function. Training will involve a daily session of 5 training tasks for 12 weeks. Each time the patient is logged in for a session, a customized report will be generated by the Lumosity program to capture performance information.
Participants' cognitive functioning will be assessed at baseline and 12 weeks using objectively measured cognitive function to estimate the preliminary efficacy of intervention program; and at 24 weeks to examine the sustained effects of the multi-component intervention program.
The findings from this project will inform a definitive phase III trial of a multi-component intervention to improve cognitive outcomes in patients with hematologic malignancy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet and Cognitive Training | Experimental | Behavioral: Modified ketogenic diet using an exogenous ketogenic formula, Behavioral: Online cognitive trainingThe 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. |
| WaitList Control | Active comparator | Behavioral: Online cognitive trainingThe arm will only use the online cognitive training program Lumosity 3 months after enrollment in the study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified ketogenic diet using an exogenous ketogenic formulaAlso: KetoCalParticipants will follow a modified ketogenic diet consuming a daily exogenous ketogenic meal replacement formula while limiting their carbohydrate intake for 12 weeks. | Behavioural | Diet and Cognitive Training |
| Online cognitive trainingAlso: LumosityParticipants will complete a daily session of 5 online cognitive training tasks for 12 weeks. | Behavioural | Diet and Cognitive Training, WaitList Control |
Primary outcome
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
Time frame: 12 weeks
Number of participants completing the 12 week intervention
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)
Time frame: Baseline to 12 weeks
Change in cognitive function will be measured using the cognitive function global deficit score (GDS) at baseline and 12 weeks comparing both active and waitlist arms. The neuropsychological test battery will include the following tests: D-KEFS Verbal Fluency, DKEFS Color-Word Interference, D-KEFS Trail Making, WAIS-IV Digit-Symbol Coding, WAIS-IV Digit Span, WAIS-IV Letter-Number Sequencing, WMS-IV Logical Memory, CVLT-II). Raw scores from the neuropsychological test battery will be transformed to standardized T-scores (mean=50; SD=10) using published normative data. T-scores will be converted to a deficit score ranging from 0 (no impairment) to 5 (severe impairment) and averaged across all tests to calculate the GDS. A lower GDS score means better cognitive function.
2 secondary outcomes
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)
Time frame: Baseline to 12 weeks for the multicomponent active arm and from 12 weeks to 24 weeks for the waitlist arm
Change in cognitive function global deficit score (GDS) from 12 wks to 24 wks in patients on the multicomponent active arm
Time frame: 12 weeks to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Noha M Sharafeldin, MD, MSc, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified ketogenic diet using an exogenous ketogenic formula and Online cognitive training in people with Cognitive Impairment and Hematologic Malignancy, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noha M Sharafeldin, MD, MSc, PhD (2056382144, nsharafeldin@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.