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Supervised Exercise for Bone Cancer
N/A
Waitlist Available
Led By Valerae O Lewis
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a new diagnosis of primary bone tumor, and whose treatment plan includes surgery
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at least 4 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at whether exercising before surgery can improve fitness in patients with bone cancer.
Who is the study for?
This trial is for patients newly diagnosed with primary bone tumors who are planning to have surgery and will receive at least 4 weeks of chemotherapy before the operation. They must be willing to wear a Fitbit and get their main cancer treatment at MD Anderson Cancer Center. Those with neurological or structural issues that prevent safe exercise, severe co-morbid illnesses, or cognitive disorders affecting safety adherence cannot join.
What is being tested?
The study is testing whether supervised exercise can improve physical fitness in bone cancer patients before they undergo surgery. Participants will engage in an exercise regimen while wearing an activity monitor (Fitbit) to track their progress.
What are the potential side effects?
While not explicitly mentioned, potential side effects may include typical risks associated with physical activity such as muscle strain, fatigue, joint pain, and increased risk of injury especially since participants have bone tumors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been newly diagnosed with a bone tumor and will undergo surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at least 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at least 4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility defined as at least 10 of out 15 patients in the supervised exercise group complete more than or equal to 75% (9 of 12 sessions) supervised physical therapy exercise sessions
Secondary study objectives
Body Weight Changes
Blood coagulation tests
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
Group I: Group II (fitbit)Experimental Treatment1 Intervention
Patients wear a fitbit.
Group II: Group I (supervised exercise)Experimental Treatment1 Intervention
Patients wear a fitbit and undergo supervised physical therapy exercise sessions over 40 minutes 3-5 times a week for at least 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Activity Monitor
2013
N/A
~320
Exercise Intervention
2016
Completed Phase 4
~1330
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,782 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,192 Total Patients Enrolled
Valerae O LewisPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
410 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can safely use exercise equipment despite my condition.I am willing to wear a Fitbit.I have been newly diagnosed with a bone tumor and will undergo surgery.I will get chemotherapy for at least 4 weeks before my surgery.I am not getting my main cancer treatment at MD Anderson.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (supervised exercise)
- Group 2: Group II (fitbit)
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.