What side effects are associated with this type of intervention?

Common treatments for brain tumors include surgery, radiation therapy, and chemotherapy. Surgery can lead to side effects such as fatigue, headaches, and cognitive changes. Radiation therapy often causes fatigue, hair loss at the treatment site, and skin changes. Chemotherapy can result in nausea, vomiting, fatigue, and increased risk of infections. These side effects can impact a patient's ability to participate in physical activities, but structured aerobic exercise training has been shown to improve physical fitness and overall health outcomes, potentially mitigating some of these adverse effects.

What prior FDA approvals exist?

FDA-approved treatments for brain tumors primarily include chemotherapeutic agents like temozolomide, often used in conjunction with radiotherapy. These treatments aim to target and reduce tumor growth. While these drugs are effective in managing the disease, they do not directly relate to improving physical fitness or overall health outcomes through structured aerobic exercise. However, integrating aerobic exercise as a supportive therapy can enhance physical fitness, reduce fatigue, and improve the quality of life for brain tumor patients undergoing these treatments.

What other types of research exist?

Promising alternatives to community-led aerobic exercise training for brain tumor patients include: 1) Supervised resistance training, which can improve muscle strength and overall physical function. 2) Mindfulness-based stress reduction programs, which can enhance mental well-being and reduce stress. 3) Web-based exercise platforms, which offer flexibility and accessibility for patients to engage in structured exercise programs from home. 4) Combined aerobic and strength training programs, which may provide comprehensive benefits for both physical and cognitive health.

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Aerobic Exercise for Brain Tumor Survivors (Fit ABCS Trial)

N/A

Recruiting

Led By Donald J Mabbott

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with a brain tumour

Medically stable (i.e. must be in remission) as determined by a permanent SickKids staff Neuro-Oncologist

Must not have

Require sedation for neuroimaging

Diagnosed with a neurodevelopmental or neurological disorder, cerebral palsy, developmental delay or learning disability prior to initial brain tumour diagnosis that would preclude safe participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a community-led exercise program using an online system is practical for children who have survived brain tumors. The kids will join group exercise sessions to help improve their fitness by keeping their heart rates up.

Who is the study for?

This trial is for children aged 6 to under 18 who have had a brain tumor, are in remission, and can understand English. They must be at least one year post-diagnosis but not more than fifteen years. A parent or guardian must agree to participate in health assessments. Kids with certain conditions, metal implants, recent cognitive therapy, or those pregnant cannot join.

What is being tested?

The study tests if a web-based aerobic exercise program led by community instructors is doable for young brain tumor survivors over 12 weeks. It aims to see if this online platform works well for delivering the training.

What are the potential side effects?

Since this trial involves an exercise program rather than medication, side effects may include typical physical activity-related issues such as muscle soreness or fatigue. However, specific side effects will depend on each child's condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a brain tumor.

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My condition is stable as confirmed by a SickKids staff Neuro-Oncologist.

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I am between 6 and 17 years old.

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English is my first language or I've studied it for two years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need medicine to help me stay calm for brain scans.

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I was diagnosed with a brain-related condition before my brain tumor that makes participation unsafe.

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I am receiving care to manage cancer symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of the exercise program: The probability that 30 eligible patients will be recruited

Feasibility of the exercise program: The probability that a recruited participant will attend ≥60% of exercise training sessions

Interventional procedure

+5 more

Other study objectives

Comparing brain function outcomes before and after community-based exercise training to a group of healthy age-matched peers

Comparing brain structure outcomes before and after community-based exercise training to a group of healthy age-matched peers

Comparing cognitive outcomes (MEG behavioral measures) before and after community-based exercise training to a group of healthy age-matched peers

+25 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FitABCS exerciseExperimental Treatment1 Intervention

Web-based community-led, 12-week exercise program

Group II: FitABCS controlActive Control1 Intervention

Healthy control

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for brain tumors include surgery, radiation therapy, chemotherapy, and exercise interventions. Surgery aims to remove the tumor, reducing symptoms and mass effect. Radiation therapy targets and destroys residual cancer cells post-surgery. Chemotherapy uses drugs to kill or inhibit cancer cell growth, often reaching the brain through the blood-brain barrier. Exercise interventions, such as community-led aerobic exercise training, enhance cardiovascular health, reduce fatigue, and improve cognitive function. These treatments are vital for brain tumor patients as they address both the tumor's direct impact and the overall health, aiming to improve survival and quality of life.

Effects of Exercise on Cancer Treatment Efficacy: A Systematic Review of Preclinical and Clinical Studies.Exercise for people with cancer: a systematic review.Motor performance in children and adolescents with cancer at the end of acute treatment phase.