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

Trial Summary

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 data supports the effectiveness of the treatment for brain tumors?

Research suggests that exercise can reduce cancer-related symptoms and improve quality of life in cancer patients, including those with brain tumors. Additionally, studies in pediatric brain tumor survivors show that exercise may enhance fitness and neuroanatomy, while nutrition interventions can improve nutritional status and quality of life. ^{1 2 3 4 5}

Is exercise safe for people with brain tumors or cancer?

Exercise programs for cancer patients, including those with brain tumors, generally appear safe with few serious adverse events. Minor issues like muscle soreness and circulatory problems can occur, but serious problems are rare, especially when the exercise is supervised. ^{6 7 8 9 10}

How is the 'Diet and Exercise for Brain Tumors' treatment different from other treatments for brain tumors?

This treatment is unique because it combines a fitness program with a modified Atkins diet, which is a high-fat, low-carbohydrate diet that induces ketosis (a state where the body burns fat for energy instead of carbohydrates). Unlike traditional treatments like surgery, radiation, and chemotherapy, this approach focuses on lifestyle changes to potentially improve quality of life and survival by altering metabolic processes and reducing cancer-related symptoms. ^{1 11 12 13 14}

What is the purpose of this trial?

This is a pilot study assessing the effects of combining a modified Atkins diet with a physical fitness regimen in patients with malignant glioma. A sample size of 15 participants will be enrolled in a 15-week program consisting of two weekly supervised exercise sessions combined with an individualized home exercise program and a modified Atkins diet.

Research Team

Lee Tessler, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Exclusion Criteria

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

Severe psychiatric illness

I have severe health conditions besides my cancer.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Conceptual development of an intensive exercise program for glioma patients (ActiNO): summary of clinical experience. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Nutrition & Exercise Interventions in Pediatric Patients with Brain Tumors: A Narrative Review. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

ACE-Neuro: A tailored exercise oncology program for neuro-oncology patients - Study protocol. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Implementing Exercise in Standard Cancer Care (Bizi Orain Hybrid Exercise Program): Protocol for a Randomized Controlled Trial. [2021]

5. United States 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

High-Intensity Physical Exercise in a Glioblastoma Patient under Multimodal Treatment. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Physical activity and cancer survivorship. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Design and Evaluation of an Outdoor Exercise Program for Pediatric Cancer Survivors. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Physical activity and fitness in adolescent and young adult long-term survivors of childhood acute lymphoblastic leukaemia. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Glycemic modulation in neuro-oncology: experience and future directions using a modified Atkins diet for high-grade brain tumors. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Exercise Improves Physical Function and Mental Health of Brain Cancer Survivors: Two Exploratory Case Studies. [2018]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Long Term Survivals in Aggressive Primary Brain Malignancies Treated With an Adjuvant Ketogenic Diet. [2023]

14. Denmark pubmed.ncbi.nlm.nih.gov

Modified Atkins diet may reduce serum concentrations of antiepileptic drugs. [2018]