Diet and Exercise for Brain Tumors

Overseen By Lee Tessler, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Severe comorbidities, Psychiatric illness, others

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

Compensation: Varies

Number of Visits: 2

Duration: 15 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a specific diet and exercise regimen can benefit individuals with malignant glioma, a type of brain tumor. Participants will follow a modified Atkins diet (a low-carbohydrate diet) and engage in a fitness program over 15 weeks. The study aims to determine if these lifestyle changes can improve health outcomes for those with this condition. Individuals diagnosed with a high-grade glioma who can participate in physical activity and dietary changes may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new lifestyle-based interventions for brain tumor patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently undergoing initial concurrent radiation or chemotherapy, you cannot participate in this trial.

What prior data suggests that this fitness program and modified Atkins diet are safe for patients with malignant glioma?

Earlier research found a supervised exercise program safe and feasible for glioma patients, regardless of cancer severity. Another study showed that exercise is safe and can enhance the quality of life for people with brain cancer. Research on a home exercise program also found it safe for patients with serious brain tumors.

A modified Atkins diet has proven safe and manageable for glioma patients undergoing treatments like radiation and chemotherapy. Another study found that this diet was well-tolerated by cancer patients with various tumor types.

These findings suggest that combining exercise with a modified Atkins diet is generally safe and well-tolerated for people with malignant glioma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of a fitness program and a modified Atkins diet for patients with malignant glioma because it offers a novel, holistic approach to treatment. Unlike traditional treatments like surgery, radiation, and chemotherapy, which directly target tumor cells, this approach aims to improve overall health and potentially enhance the body's resilience to disease. The fitness program and diet could potentially improve brain function, quality of life, and even slow tumor progression by optimizing metabolic health and physical fitness. This approach could complement existing therapies, offering a non-invasive strategy with additional benefits for brain tumor patients.

What evidence suggests that this trial's treatments could be effective for brain tumors?

This trial will evaluate the effects of a combined fitness program and modified Atkins diet for patients diagnosed with malignant glioma. Research has shown that exercise benefits people with brain tumors, including malignant glioma. Studies have found that physical activity can boost well-being and slow the loss of physical abilities. Exercise might also enhance brain tumor treatments by helping the brain absorb these drugs more effectively.

Regarding diet, the modified Atkins diet has proven safe and manageable for glioma patients. Early research suggests this diet could enhance radiation therapy by reducing the sugar available to tumors, which they need to grow. This diet also led to positive outcomes, such as increased ketones in the urine, which might help starve the tumor. ^{2 6 7 8 9}

Who Is on the Research Team?

Lee Tessler, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals with malignant glioma, a type of brain tumor. Participants will engage in a 15-week program that includes diet and exercise changes. Specific eligibility details are not provided, but typically participants must meet certain health criteria to ensure safety.

Inclusion Criteria

Able to give full informed consent

I am able to care for myself but may not be able to do active work.

I am willing to follow the study's treatment and check-up plan.

Exclusion Criteria

I cannot do moderate to vigorous exercise due to a health condition.

Severe psychiatric illness

Any medical condition which prohibits a restrictive diet

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 15-week program combining a modified Atkins diet with a physical fitness regimen, including two weekly supervised exercise sessions and an individualized home exercise program

15 weeks

2 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fitness Program
• Modified Atkins Diet

Trial Overview

The study is testing the combination of a modified Atkins diet and a fitness program on patients with malignant glioma. It involves two supervised exercise sessions per week, an individualized home exercise plan, and adherence to the specialized diet.

How Is the Trial Designed?

Group I: Patients Diagnosed with Malignant Glioma Experimental Treatment 2 Interventions

Patients will participate in a 15-week program consisting of two weekly supervised exercise sessions combined with an individualized home exercise program and a modified Atkins diet.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

A study of 21 long-term survivors of childhood acute lymphoblastic leukemia (ALL) revealed that their peak oxygen uptake (VO2 peak) was 14% lower than that of age- and sex-matched controls, indicating poorer cardiovascular fitness.

The findings highlight that a significant portion of survivors, especially females, exhibit very low levels of physical activity, emphasizing the need for promoting physical activity to improve fitness and reduce long-term health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and fitness in adolescent and young adult long-term survivors of childhood acute lymphoblastic leukaemia. Järvelä, LS., Niinikoski, H., Lähteenmäki, PM., et al.[2021]

The ACE-Neuro study aims to evaluate the feasibility of a tailored 12-week exercise program for neuro-oncology patients in Alberta, Canada, addressing a gap in access to exercise oncology resources for these patients.

Participants in the study will undergo assessments of patient-reported outcomes and functional fitness before and after the program, which includes both individual and group exercise sessions, indicating a comprehensive approach to improving their health and wellness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACE-Neuro: A tailored exercise oncology program for neuro-oncology patients - Study protocol. Daun, JT., Capozzi, LC., Roldan Urgoiti, G., et al.[2022]

A submaximal exercise program for glioma patients, consisting of individualized sessions of bicycle ergometry and resistance training, was found to be safe and feasible, with only two minor epileptic events reported during 1828 training sessions.

Patients participating in the program achieved significant cardiorespiratory fitness, with a median survival of 24.1 months for glioblastoma patients, suggesting that exercise may positively impact their overall health and longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conceptual development of an intensive exercise program for glioma patients (ActiNO): summary of clinical experience. Jost, J., Müther, M., Brandt, R., et al.[2023]

A ketogenic diet (KD) combined with standard treatments for aggressive primary brain tumors (APBT) showed promising results, with three younger patients surviving significantly longer (52-74 months) compared to older patients, who had an average survival of 8 months after diagnosis.

The study demonstrated that it is feasible to maintain dietary-induced ketosis in patients with APBT, suggesting that further research is needed to explore the potential benefits of KD, particularly in younger patients under 40.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long Term Survivals in Aggressive Primary Brain Malignancies Treated With an Adjuvant Ketogenic Diet. Schwartz, KA., Noel, M., Nikolai, M., et al.[2023]

In a study of 35,110 exercise interventions for pediatric cancer patients and survivors, serious adverse events (AEs) were rare, with only six Grade 2-3 AEs reported, resulting in an incidence of 17 per 100,000 interventions, indicating that supervised exercise programs are generally safe.

While Grade 1 AEs, such as muscle soreness and circulatory problems, were more common (2,800 per 100,000 interventions), these were typically mild and likely not directly caused by the exercise, suggesting that exercise can be safely integrated into cancer care for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. Gauß, G., Beller, R., Boos, J., et al.[2021]

High-fat, low-carbohydrate diets, like the modified Atkins diet, have been used for over a century in managing neurological diseases and show promise in disrupting cancer metabolism, particularly in neuro-oncology.

Recent studies indicate that dietary interventions can have antitumor effects and may enhance treatment strategies for primary malignant brain tumors, warranting further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycemic modulation in neuro-oncology: experience and future directions using a modified Atkins diet for high-grade brain tumors. Strowd, RE., Cervenka, MC., Henry, BJ., et al.[2022]

Regular physical activity is safe and beneficial for cancer survivors, leading to improvements in weight management, fitness, quality of life, and psychological health outcomes.

Healthcare providers should customize physical activity programs for cancer survivors to enhance adherence and meet individual needs, as current research lacks thorough examination of specific cancer types and their unique requirements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and cancer survivorship. Garcia, DO., Thomson, CA.[2022]

In a study involving four adult patients with drug-resistant epilepsy, the modified Atkins diet led to a significant average reduction of 35% in serum concentrations of antiepileptic drugs (AEDs) after 12 weeks, indicating a potential pharmacokinetic interaction.

This reduction in AED levels could have clinical implications for patients, suggesting that careful monitoring of AED serum concentrations is necessary when implementing the modified Atkins diet as an add-on therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified Atkins diet may reduce serum concentrations of antiepileptic drugs. Kverneland, M., Taubøll, E., Selmer, KK., et al.[2018]

A regional outdoor exercise program for pediatric cancer survivors showed high participation and enthusiasm, with 26 survivors engaging in various activities over one year and no adverse events reported during 302 hours of physical activity.

The main motivation for participation was the opportunity to try new sports, while a significant barrier was the fear of not being able to keep up with peers, indicating the need for supportive environments to boost confidence in continuing exercise independently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Evaluation of an Outdoor Exercise Program for Pediatric Cancer Survivors. Blosch, C., Krombholz, A., Beller, R., et al.[2022]

A 12-week structured exercise program was well tolerated by two female brain cancer patients, with no adverse effects reported, indicating that exercise can be safely integrated into their treatment plans.

Both participants showed significant improvements in physical strength, cardiovascular fitness, and psychological well-being, including reduced anxiety and depression, suggesting that exercise may enhance quality of life for brain cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Improves Physical Function and Mental Health of Brain Cancer Survivors: Two Exploratory Case Studies. Levin, GT., Greenwood, KM., Singh, F., et al.[2018]

A case study of a 33-year-old male GBM patient showed that he could safely engage in high-intensity exercise for 87 weeks during treatment, without any adverse events, suggesting that exercise may be feasible for GBM patients.

Despite ongoing tumor progression and intensive therapies, the patient improved his fitness levels and completed two marathons, indicating that structured exercise programs could potentially benefit GBM patients and should be further investigated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Physical Exercise in a Glioblastoma Patient under Multimodal Treatment. Troschel, FM., Brandt, R., Wiewrodt, R., et al.[2020]

Nutrition interventions, such as proactive feeding tubes and nutritional supplementation, have shown improvements in nutritional status for pediatric brain tumor patients, highlighting the importance of addressing dietary needs during treatment.

Exercise interventions have been linked to better fitness and neuroanatomy in survivors of pediatric brain tumors, suggesting that physical activity may enhance quality of life, warranting further controlled studies to solidify these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition & Exercise Interventions in Pediatric Patients with Brain Tumors: A Narrative Review. Runco, DV., Yoon, L., Grooss, SA., et al.[2020]

The Bizi Orain exercise program, a community-based initiative for cancer patients, aims to improve cardiorespiratory function and quality of life through a 3-month supervised exercise regimen, with 265 patients enrolled since January 2019.

This program is significant as it represents the first population-based exercise initiative in Spain designed to integrate structured physical activity into cancer care, potentially enhancing patient survival and reducing treatment-related adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Exercise in Standard Cancer Care (Bizi Orain Hybrid Exercise Program): Protocol for a Randomized Controlled Trial. Arietaleanizbeaskoa, MS., Gil Rey, E., Mendizabal Gallastegui, N., et al.[2021]

A lifestyle intervention involving diet and physical activity led to significant weight loss (5.6 kg) and improvements in body composition among 37 overweight and obese breast cancer survivors who completed the program.

Participants showed substantial reductions in energy and fat intake, along with improvements in quality of life and cardiorespiratory fitness, indicating the intervention's effectiveness in promoting healthier lifestyles post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a diet and physical activity intervention on body weight and nutritional patterns in overweight and obese breast cancer survivors. Travier, N., Fonseca-Nunes, A., Javierre, C., et al.[2021]

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Diet and Exercise for Brain Tumors

This is a pilot study assessing the effects of combining a modified Atkins diet with a physical fitness regimen in patients with malignant glioma.