Supervised Exercise in Improving Physical Fitness Before Surgery in Patients With Resectable Bone Cancer
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|ClinicalTrials.gov Identifier: NCT02893397|
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : June 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Malignant Bone Neoplasm||Device: Activity Monitor Behavioral: Exercise Intervention||Not Applicable|
I. To determine if regular exercise, which may improve delivery and efficacy of chemotherapy, is feasible in children and young adults with malignant bone tumors undergoing neoadjuvant chemotherapy.
I. To determine if exercise results in a change in tumor vascularity as evidenced by magnetic resonance imaging (MRI) in children and young adults with malignant bone tumors who participate in structured aerobic exercise as compared to children and young adults who do not.
II. To determine whether serum levels of thrombospondin-1, an endogenous anti-angiogenic protein, and sphingosine-1-phosphate, an angiogenic modulator, increase in children and young adults with malignant bone tumors who participate in supervised aerobic exercise over a 4 week period of time during neoadjuvant chemotherapy.
III. To determine if aerobic exercise decreases reactive oxygen species (ROS) in the peripheral blood of bone sarcoma patients.
IV. To determine if the numbers of circulating tumor cells decrease in patients who participate in supervised exercise over a 4 week period of time.
V. To determine whether a home-based exercise program or supervised exercise program is more feasible for this patient population.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients wear a fitbit and undergo supervised physical therapy exercise sessions over 40 minutes 3-5 times a week for at least 4 weeks.
GROUP II: Patients wear a fitbit.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Pre-Surgical Supervised Exercise for Bone Cancer Patients|
|Actual Study Start Date :||August 30, 2016|
|Estimated Primary Completion Date :||August 30, 2020|
|Estimated Study Completion Date :||August 30, 2021|
Experimental: Group I (supervised exercise)
Patients wear a fitbit and undergo supervised physical therapy exercise sessions over 40 minutes 3-5 times a week for at least 4 weeks.
Behavioral: Exercise Intervention
Undergo supervised exercise sessions
Experimental: Group II (fitbit)
Patients wear a fitbit.
Device: Activity Monitor
Wear a fitbit
- 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 [ Time Frame: At least 4 weeks ]Completion of daily exercise is defined as at least 20 minutes of aerobic exercise achieved within heart rate and blood pressure that the licensed physical therapist has determined is safe for the patient on that given day.
- Change in tumor vascularity as measured by magnetic resonance imaging diffusion studies [ Time Frame: Baseline up to 4 weeks ]Will use a two-sided t-test with a significance level of 5% to compare the tumor vascularity between groups.
- Change in tumor vascularity as measured by blood serum analysis of serum thrombospondin-1 and sphingosine-1-phosphate [ Time Frame: Baseline up to 4 weeks ]Will use a two-sided t-test with a significance level of 5% to compare the tumor vascularity between groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02893397
|Contact: Valerae O. Lewis, BS,MDfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Valerae O. Lewis 713-745-4117|
|Principal Investigator: Valerae O. Lewis|
|Principal Investigator:||Valerae O Lewis||M.D. Anderson Cancer Center|