80 Participants Needed

Diet and Cognitive Training for Blood Cancer Survivors

NM
LH
Overseen ByLindsey Hageman, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The ketogenic diet has been used safely in humans for various conditions, including epilepsy, cancer, and neurological diseases. It is generally considered safe when monitored by healthcare professionals, although some skepticism about its safety exists, particularly in cancer patients.678910

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

NM

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

I finished my bone marrow transplant over 3 months ago or was diagnosed over 6 months ago without a transplant.
Can understand and sign the study-specific Informed Consent Form
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
See 3 more

Exclusion Criteria

History of pre-existing neurological disorder or documented major psychiatric disorder
History of pre-existing metabolic disease
History of color blindness
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention arm consume an exogenous ketogenic supplementation and use an online cognitive training program for 12 weeks

12 weeks

Waitlist Control

Participants in the waitlist control arm receive the online cognitive training program after a wait period of 12 weeks

12 weeks

Follow-up

Participants are monitored for sustained effects of the intervention program

12 weeks

Treatment Details

Interventions

  • Modified ketogenic diet using an exogenous ketogenic formula
  • Online cognitive training
Trial OverviewThe trial is testing whether a special diet (modified ketogenic) plus brain exercises online can help improve thinking skills in blood cancer survivors better than just waiting for treatment. Participants will use the diet supplement and do brain training for 12 weeks while their progress is compared to others who wait before starting the program.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Diet and Cognitive TrainingExperimental Treatment2 Interventions
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.
Group II: WaitList ControlActive Control1 Intervention
The arm will only use the online cognitive training program Lumosity 3 months after enrollment in the study.

Modified ketogenic diet using an exogenous ketogenic formula is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Ketogenic diet for:
  • Pediatric epilepsy
  • Glioblastoma (as part of clinical trials)
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Approved in European Union as Ketogenic diet for:
  • 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

Trials
1,677
Recruited
2,458,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Cognitive impairment is a common issue for cancer survivors, and while research is increasing, there are still many unanswered questions about its causes and how to effectively manage it.
A review of current literature found that both nonpharmacologic and pharmacologic interventions for cognitive impairment in cancer survivors have not yet established effectiveness, indicating a need for further research to identify viable treatment options.
Putting evidence into practice: evidence-based interventions for cancer and cancer treatment-related cognitive impairment.Von Ah, D., Jansen, C., Allen, DH., et al.[2015]
An 8-week home-based computerized cognitive training (CCT) program was assessed for feasibility among 19 patients recently treated for hematological malignancies, but adherence was low, with only one participant fully engaging with the program.
Participants found the CCT program easy to follow and expressed a need for improvements, such as personalized feedback and peer support, to enhance adherence, indicating that while CCT may be beneficial, additional support strategies are necessary for effective implementation in the post-treatment phase.
Computerized cognitive training in post-treatment hematological cancer survivors: a feasibility study.Mayo, SJ., Rourke, SB., Atenafu, EG., et al.[2021]
In a randomized controlled trial involving 363 female breast cancer survivors, the internet-based intervention 'Optimune' significantly improved quality of life and dietary habits after three months compared to usual care alone.
While the intervention showed positive effects on quality of life (effect size d = 0.27) and dietary habits (effect size d = 0.36), it did not significantly increase physical activity levels (effect size d = 0.30).
Results of the Optimune trial: A randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors.Holtdirk, F., Mehnert, A., Weiss, M., et al.[2023]

References

Putting evidence into practice: evidence-based interventions for cancer and cancer treatment-related cognitive impairment. [2015]
Computerized cognitive training in post-treatment hematological cancer survivors: a feasibility study. [2021]
Results of the Optimune trial: A randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors. [2023]
eHealth cognitive rehabilitation for brain tumor patients: results of a randomized controlled trial. [2022]
Interventions promoting cognitive function in patients experiencing cancer related cognitive impairment: A systematic review. [2023]
Ketogenic diet experience at Ondokuz Mayฤฑs University. [2021]
The ketogenic diet in infants--Advantages of early use. [2022]
Cognitive and behavioral impact of the ketogenic diet in children and adolescents with refractory epilepsy: A randomized controlled trial. [2018]
Ketogenic diets consumed during radio-chemotherapy have beneficial effects on quality of life and metabolic health in patients with rectal cancer. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
The ketogenic diet is an effective adjuvant to radiation therapy for the treatment of malignant glioma. [2022]
Effect of cognitive training on patients with breast cancer reporting cognitive changes: a systematic review and meta-analysis. [2023]
Cognitive Retraining and Functional Treatment (CRAFT) for adults with cancer related cognitive impairment: a preliminary efficacy study. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Occupational Therapists With Oncology Exposure: Perceived Needs on Adults and Older Adults With Cancer-Related Cognitive Impairments. [2018]