Diet and Cognitive Training for Blood Cancer Survivors

Overseen By Lindsey Hageman, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Neurological, Psychiatric, GvHD, Metabolic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining a special diet with brain training can improve thinking skills in blood cancer survivors. Participants will either follow a modified ketogenic diet using an exogenous ketogenic formula (a low-carb, high-fat diet) and use an online brain training program, or only engage in brain training after a waiting period. The goal is to determine if this combination affects cognitive functions and the duration of any benefits. Suitable candidates are those who have had blood cancer, completed treatment at least three months ago, and experience memory or thinking difficulties. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance cognitive recovery strategies for blood cancer survivors.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ketogenic diets are generally safe and well-tolerated by cancer patients. For example, past studies found that these diets can help reduce tiredness and improve sleep. They also help lower insulin and blood sugar levels.

Regarding online brain training, studies have shown that these programs are safe for cancer survivors. Participants did not report major side effects, and the programs may even help improve thinking skills.

Both the ketogenic diet and online brain training have been tested in various settings and are considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for blood cancer survivors because they combine a modified ketogenic diet with cognitive training to potentially improve brain health. Unlike standard therapies that often focus solely on medical or drug interventions, this approach uses an exogenous ketogenic formula (KetoCal) to provide a unique source of energy that may support brain function. Additionally, the use of the online cognitive training program Lumosity aims to enhance cognitive skills, offering a non-invasive and accessible method to possibly boost mental agility. This combination of diet and cognitive exercises might offer a holistic way to address cognitive challenges faced by survivors, highlighting an innovative approach beyond typical treatment regimens.

What evidence suggests that this trial's treatments could be effective for improving cognitive functioning in blood cancer survivors?

Studies have shown that a ketogenic diet, which involves eating low carbs and high fats, can help cancer patients feel better and manage their symptoms. It can also improve their overall health. Similarly, research suggests that online brain training programs can enhance memory and attention in cancer survivors, which might be affected by cancer treatments. Although the benefits of brain training can sometimes be small, they still show promise for improving mental health. In this trial, one arm will use both a modified ketogenic diet with an exogenous ketogenic formula and an online cognitive training program, potentially offering additional benefits for blood cancer survivors seeking to boost brain function. ^{1 2 6 7 8}

Who Is on the Research Team?

Noha Sharafeldin, MD, MSc, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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

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

Exclusion Criteria

History of pre-existing metabolic disease

History of pre-existing neurological disorder or documented major psychiatric disorder

History of color blindness

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Modified ketogenic diet using an exogenous ketogenic formula
• Online cognitive training

Trial Overview

The 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.

How Is the Trial Designed?

Group I: Diet and Cognitive Training Experimental Treatment 2 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 Control Active Control 1 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:

Approved in United States as Ketogenic diet for:

• Pediatric epilepsy
• Glioblastoma (as part of clinical trials)

Approved in European Union as Ketogenic diet for:

• Pediatric epilepsy
• Glioblastoma (as part of clinical trials)

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+

Published Research Related to This Trial

Cognitive training has been shown to significantly improve subjective cognitive function and certain objective cognitive skills, such as working memory and episodic memory, in breast cancer patients experiencing cognitive changes, based on a systematic review of 9 randomized controlled trials involving 666 patients.

Despite these improvements, cognitive training did not lead to significant changes in attention, short-term memory, executive function, or psychological outcomes like anxiety and depression, indicating that while cognitive training can be beneficial, it may not address all cognitive and emotional challenges faced by these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of cognitive training on patients with breast cancer reporting cognitive changes: a systematic review and meta-analysis. Yan, X., Wei, S., Liu, Q.[2023]

A survey of 107 occupational therapists revealed that 92% believe attending a face-to-face continuing education program on cancer-related cognitive impairments (CRCI) would be beneficial, highlighting a strong demand for further training in this area.

The study identified specific content and design preferences for continuing competency seminars, indicating a clear direction for developing educational programs that address the knowledge gaps of occupational therapists regarding CRCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational Therapists With Oncology Exposure: Perceived Needs on Adults and Older Adults With Cancer-Related Cognitive Impairments. Ulfers, SS., Berg, C.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in post-treatment hematological cancer survivors: a feasibility study. Mayo, SJ., Rourke, SB., Atenafu, EG., et al.[2021]

A study involving 74 adults with cancer-related cognitive impairment showed that the Cognitive Retraining and Functional Treatment (CRAFT) program, which combines cognitive training and occupation-based treatment, significantly improved participation in daily life and cognitive performance compared to standard treatment.

CRAFT not only enhanced cognitive outcomes but also led to greater treatment satisfaction and maintained these benefits at a 3-month follow-up, indicating its potential as an effective intervention for improving quality of life in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Retraining and Functional Treatment (CRAFT) for adults with cancer related cognitive impairment: a preliminary efficacy study. Maeir, T., Makranz, C., Peretz, T., et al.[2023]

In a retrospective analysis of 14 patients on the ketogenic diet (KD) for epilepsy, 3 patients became seizure-free and 7 experienced a reduction of at least 50% in their seizures, demonstrating the diet's potential efficacy in managing resistant epilepsy.

Despite positive outcomes, some patients discontinued the KD due to issues like frequent infections, family concerns, and financial difficulties, highlighting the need for ongoing support and consideration of individual circumstances in treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic diet experience at Ondokuz Mayıs University. Tekin, E., Serdaroğlu, FM., Şahin, Ş., et al.[2021]

The ketogenic diet (KD) is highly effective for infants under 1.5 years with epilepsy, showing a higher rate of seizure freedom compared to older children, with 34.5% of infants becoming seizure-free at 3 months versus 19% in older children.

The KD was well tolerated in infants, with no significant safety concerns, and acceptance of the diet was better in infants before they started solid foods, suggesting that early implementation of the KD may be beneficial for managing epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ketogenic diet in infants--Advantages of early use. Dressler, A., Trimmel-Schwahofer, P., Reithofer, E., et al.[2022]

In a study of 41 rectal cancer patients undergoing radio-chemotherapy, those on a ketogenic diet (KD) reported better quality of life and improved emotional and social functioning compared to those on a standard diet (SD).

The KD group also showed improvements in several metabolic health markers, while the SD group experienced declines in physical functioning and increased symptoms like fatigue, suggesting that KDs may be a beneficial complementary therapy during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic diets consumed during radio-chemotherapy have beneficial effects on quality of life and metabolic health in patients with rectal cancer. Klement, RJ., Meyer, D., Kanzler, S., et al.[2022]

In a mouse model of malignant glioma, a ketogenic diet (KetoCal®) significantly increased survival by approximately 5 days compared to a standard diet, indicating its potential as a supportive treatment in cancer therapy.

The combination of the ketogenic diet and radiation therapy showed more than additive effects, with tumor growth significantly reduced in most mice on the ketogenic diet, suggesting that metabolic changes from the diet could enhance the effectiveness of conventional cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ketogenic diet is an effective adjuvant to radiation therapy for the treatment of malignant glioma. Abdelwahab, MG., Fenton, KE., Preul, MC., et al.[2022]

A tablet-based cognitive rehabilitation program called ReMind was evaluated in 62 brain tumor patients, but it did not show significant improvements in cognitive performance or psychological outcomes compared to a control group.

Despite the lack of statistical significance in cognitive outcomes, participants reported high satisfaction with the program, indicating that while the intervention may not have been effective in this study, it could still be beneficial if tailored to better meet patients' needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

eHealth cognitive rehabilitation for brain tumor patients: results of a randomized controlled trial. van der Linden, SD., Rutten, GM., Dirven, L., et al.[2022]

In a study involving 50 children and adolescents with refractory epilepsy, those on the ketogenic diet (KD) showed significant improvements in behavior, including lower anxiety and mood disturbances, compared to a control group receiving standard care.

Cognitive assessments indicated that the KD group experienced enhanced cognitive activation, suggesting that the diet not only helps reduce seizures but may also positively influence mood and cognitive functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive and behavioral impact of the ketogenic diet in children and adolescents with refractory epilepsy: A randomized controlled trial. IJff, DM., Postulart, D., Lambrechts, DAJE., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A systematic review of 31 studies found that various interventions, such as cognitive behavioral therapy and brain training, show promise in improving cognitive function in cancer patients experiencing cognitive impairment after chemotherapy.

The study highlighted inconsistencies in outcome measurements across different interventions, suggesting a need for standardized assessment tools in future research to better evaluate the effectiveness of these cognitive enhancement strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions promoting cognitive function in patients experiencing cancer related cognitive impairment: A systematic review. Oldacres, L., Hegarty, J., O'Regan, P., et al.[2023]

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