Virtual Exercise Program for Brain Cancer

Overseen By Keri L Schadler, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Non-English, Cardiac disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new virtual exercise program for young people with brain tumors who are planning to undergo cranial radiotherapy, a treatment targeting the brain. The study examines how exercise can assist during this challenging time. Participants will wear an ActiGraph device to track physical activity, such as steps and time spent moving. Ideal candidates are adolescents and young adults with a brain tumor who are about to start or have recently started cranial radiotherapy and currently engage in less than 150 minutes of planned exercise per week. Participants must be able to move safely, have a smartphone, and access the internet. As an unphased trial, this study offers a unique opportunity to explore how exercise might enhance the treatment experience.

Do I need to stop my current medications for the trial?

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 prior data suggests that this virtual exercise program is safe for adolescents and young adults with brain tumors?

Research has shown that exercise is generally safe for people with brain cancer. Early findings suggest that exercise can enhance their quality of life and physical abilities. Studies have found that exercise programs, whether done at home or online, are safe and feasible for people with brain tumors. One study found no negative side effects. Participants in these programs often became stronger and more physically capable. Overall, exercise appears to be a well-tolerated option for those receiving treatment for brain cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Exercise Program for brain cancer because it offers a new approach to enhancing patient well-being through physical activity. Unlike traditional treatments like surgery, chemotherapy, and radiation, which focus on directly attacking cancer cells, this program aims to improve overall health and potentially boost recovery by increasing physical activity. The use of a wearable device, the ActiGraph, provides precise data on a patient's daily activity levels, offering insights into how lifestyle changes could support treatment outcomes. This innovative approach could lead to improved quality of life and potentially better treatment responses for brain cancer patients.

What evidence suggests that this virtual exercise program is effective for brain cancer?

Research has shown that exercise can enhance well-being and physical abilities in people with brain cancer. One study found that a virtual exercise program boosted physical activity and brain function in young brain tumor survivors. Another study showed that exercise did not negatively affect survival rates for those with severe brain tumors. Additionally, a home-based exercise program proved safe and beneficial, improving quality of life and physical abilities for brain cancer patients. These findings suggest that the virtual exercise program tested in this trial could support physical and mental health during treatment. ^{1 3 6 7 8}

Who Is on the Research Team?

Maria L Schadler, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults aged 15-39 with brain tumors who are about to undergo radiotherapy. They must be able to move, have internet access, a smartphone, and be willing to use a Fitbit. Participants should not be very active currently and cannot join if they're non-English speakers, pregnant, have unstable heart/lung conditions or injuries that prevent exercise.

Inclusion Criteria

Participants and/or guardians are willing and able to provide informed consent

Received appropriate physician clearance

I can move my arms and legs and walk safely.

Exclusion Criteria

You are currently participating in another exercise program.

I have a recent injury that stops me from joining exercise sessions.

Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q).12

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy

Participants undergo cranial radiotherapy (CRT) as part of their treatment for brain tumors

Varies based on individual treatment plans

Exercise Intervention

Participants engage in a virtually supervised exercise program to mitigate cognitive deficits from radiotherapy

Throughout the radiotherapy phase

Virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cognitive function and quality of life assessments

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Exercise Program

Trial Overview

The study is testing a new virtual exercise program against the standard Fitbit program in young people with brain tumors receiving radiotherapy. The goal is to see if the virtual exercises can help reduce cognitive deficits caused by the treatment.

How Is the Trial Designed?

Group I: Actigraph Experimental Treatment 2 Interventions

A device worn on the waist that measures physical activity (such as the number of steps participants walk each day, how long participants spend standing, and how long partticipants spend laying down). Participants should wear the ActiGraph at least 10 hours a day for 7 days.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

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]

An 18-week exercise intervention for adults with primary brain cancer was found to be safe, with no serious adverse events reported, and feasible, achieving high recruitment (80%) and retention (92%) rates.

Participants showed significant improvements in quality of life, functional well-being, and various physical fitness measures, indicating that exercise can be beneficial for individuals recovering from brain cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety, feasibility, and efficacy of an 18-week exercise intervention for adults with primary brain cancer - the BRACE study. Sandler, CX., Gildea, GC., Spence, RR., 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]

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]

The 8-week group-based physical activity program delivered via videoconferencing was feasible and well-accepted by cancer survivors, with high enrollment (61 out of 65 interested) and retention rates (86.9%).

Participants showed significant improvements in physical activity levels, muscular endurance, and quality of life after the program, indicating that this innovative approach may effectively support cancer survivors in increasing their physical activity and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Group-Based, Videoconference-Delivered Physical Activity Program for Cancer Survivors. Leach, HJ., Crisafio, ME., Howell, MJ., et al.[2023]

The ADVANCE study aims to evaluate how adverse events (AEs) are reported in exercise oncology trials, which is crucial for assessing the safety of exercise interventions for cancer patients.

By reviewing published trials and using a standardized checklist for reporting AEs, the study seeks to identify gaps in current practices and inform future research on improving the consistency and transparency of AE reporting in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. Luo, H., Schumacher, O., Galvão, DA., et al.[2022]

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