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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

To test a new investigational virtual exercise program for adolescents and young adults (AYAs) with brain tumors who plan to receive cranial radiotherapy

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 data supports the effectiveness of the treatment Virtual Exercise Program for brain cancer?

Research shows that exercise can improve physical function and mental health in brain cancer survivors, as seen in two case studies where participants experienced better strength, fitness, and mood. Additionally, a study on augmented-reality-based exercises for high-grade glioma patients found improvements in quality of life and mood, suggesting that exercise programs, including virtual ones, may be beneficial. ^{1 2 3 4 5}

Is the Virtual Exercise Program safe for brain cancer patients?

Research shows that exercise programs, including virtual ones, are generally safe for brain cancer patients. In studies, participants completed exercise sessions without any serious side effects, and minor issues like muscle soreness were rare and not life-threatening. ^{1 2 3 6 7}

How is the Virtual Exercise Program treatment different from other treatments for brain cancer?

The Virtual Exercise Program is unique because it uses a virtual platform to deliver exercise sessions, which can improve physical function and mental health in brain cancer patients. Unlike traditional treatments that focus solely on medical interventions, this program offers a supportive therapy that enhances quality of life and reduces treatment-related health declines. ^{1 3 5 8 9}

Research Team

Maria L Schadler, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

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

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

2. Switzerland pubmed.ncbi.nlm.nih.gov

Rehabilitation Exercises Supported by Monitor-Augmented Reality for Patients with High-Grade Glioma Undergoing Radiotherapy: Results of a Randomized Clinical Trial. [2023]

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

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

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

Physical activity and exercise in adults diagnosed with primary brain cancer: a systematic review. [2022]

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

A Group-Based, Videoconference-Delivered Physical Activity Program for Cancer Survivors. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. [2022]

8. England 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. [2023]

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

Voluntary Physical Exercise Reduces Motor Dysfunction and Hampers Tumor Cell Proliferation in a Mouse Model of Glioma. [2020]