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Physical Activity for Brain Cancer

Phase 2
Recruiting
Led By Pamela L Wolters, Ph.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children ages 8 - 18 years of age, diagnosed with brain tumor in childhood
Must be off anti-neoplastic therapy for at least 2 weeks and all therapy-related toxicities should return to baseline or less than or equal to Grade 1 if previously nonexistent
Must not have
A child with diffuse intrinsic pontine glioma (DIPG) or recurrent high grade brain tumors
Currently on or planning to begin active neoplastic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Summary

This trial is testing whether physical activity can improve cognitive function in children who had radiation therapy for a brain tumor.

Who is the study for?
This trial is for children aged 8-17 who had radiation for a brain tumor at least two years ago, can read and understand English, have access to a computer or smart device, and are willing to participate in physical activities. They should not be on recent cancer therapy with significant side effects and must have parental support.
What is being tested?
The study tests if regular physical activity improves attention, memory, and other cognitive functions in children treated with cranial radiation for brain tumors. It involves fitness exams, blood tests, questionnaires about daily activities over a 24-week period with follow-up visits.
What are the potential side effects?
Since the intervention involves physical activity rather than medication or invasive procedures, no direct medical side effects are expected. However, there may be general risks associated with increased physical activity such as muscle strain or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was diagnosed with a brain tumor as a child and am between 8 and 18 years old.
Select...
I haven't had cancer treatment for 2 weeks and any side effects are mild or gone.
Select...
I completed radiation therapy to my brain or brain and spine over a year ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My child has a specific type of brain tumor known as DIPG or a recurrent high-grade brain tumor.
Select...
I am currently undergoing or about to start cancer treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy
Secondary study objectives
compare cognitive test scores between groups
effects of 12wk PA on cognitive functions
effects of 12wk PA on fatigue, sleep and QOL
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment1 Intervention
enhanced PA home intervention group for the first 12 weeks; followed by 12 weeks of PA maintenance on their own.
Group II: 2Active Control1 Intervention
usual physical activity (no intervention) for 12 weeks; followed by the enhanced PA home intervention for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Physical Activity
2019
Completed Phase 3
~4780

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,844 Total Patients Enrolled
Pamela L Wolters, Ph.D.Principal InvestigatorNational Cancer Institute (NCI)
4 Previous Clinical Trials
1,214 Total Patients Enrolled

Media Library

Physical Activity Clinical Trial Eligibility Overview. Trial Name: NCT02153957 — Phase 2
Brain Tumor Research Study Groups: 2, 1
Brain Tumor Clinical Trial 2023: Physical Activity Highlights & Side Effects. Trial Name: NCT02153957 — Phase 2
Physical Activity 2023 Treatment Timeline for Medical Study. Trial Name: NCT02153957 — Phase 2
~11 spots leftby Jun 2025