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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy
Secondary outcome measures
compare cognitive test scores between groups
effects of 12wk PA on cognitive functions
effects of 12wk PA on fatigue, sleep and QOL
+3 moreTrial 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
~4710
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,924,485 Total Patients Enrolled
Pamela L Wolters, Ph.D.Principal InvestigatorNational Cancer Institute (NCI)
3 Previous Clinical Trials
1,266 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child has a specific type of brain tumor known as DIPG or a recurrent high-grade brain tumor.I am currently undergoing or about to start cancer treatment.I have severe health issues that prevent me from doing moderate to vigorous exercise.My child has cognitive or emotional issues that may hinder participation in the study.I was diagnosed with a brain tumor as a child and am between 8 and 18 years old.You have been reported to have trouble with paying attention, thinking quickly, remembering things, or learning new information.I haven't had cancer treatment for 2 weeks and any side effects are mild or gone.You exercise vigorously for more than 3 hours a week.I can understand and am willing to sign the consent form.I completed radiation therapy to my brain or brain and spine over a year ago.My child is starting treatment for attention/memory issues soon.
Research Study Groups:
This trial has the following groups:- Group 1: 2
- Group 2: 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total number of participants in this research project?
"That is accurate. The information available on clinicaltrials.gov demonstrates that this trial is presently looking for candidates. This specific clinical trial was first posted on 8/21/2014 and was most recently updated on 11/4/2022. Additionally, the trial is recruiting for 156 patients at 2 sites."
Answered by AI
Are participants being enrolled in this experiment at this time?
"This trial is open and looking for volunteers. The clinical study was originally posted on 8/21/2014, with the most recent update being on 11/4/2022."
Answered by AI
Is there a danger in partaking of Physical Activity?
"While there is some evidence backing the safety of physical activity, its efficacy has not been clinically proven. Therefore, it received a score of 2."
Answered by AI
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