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Trial record 10 of 4290 for:    bone tumors AND NOT metastatic

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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This clinical trial studies how well supervised exercise works in improving physical fitness before surgery in patients with bone cancer that can be removed by surgery. Supervised exercise may provide better short-term physical fitness in patients with bone cancer.

Condition or disease Intervention/treatment Phase
Malignant Bone Neoplasm Device: Activity Monitor Behavioral: Exercise Intervention Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
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


Arm Intervention/treatment
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
Other Names:
  • Activity Tracker
  • Activity Tracker Device
  • Physical Activity Measuring Device




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   5 Years to 39 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a new diagnosis of primary bone tumor, and whose treatment plan includes surgery
  • Patients who are expected to receive at least 4 weeks of neoadjuvant chemotherapy treatment between enrollment in the study and planned surgery
  • Participants willing to wear a Fitbit

Exclusion Criteria:

  • Patients who are not receiving their primary cancer care (surgery and chemotherapy) at MD Anderson Cancer Center (participants from the supervised exercise group only)
  • Patients who have a cognitive disorder which impacts the ability to follow directions or adhere to safety rules; this will be determined by the physical therapist by assessing whether a neurological disorder or musculoskeletal disorder would prevent the patient from safely exercising
  • Patients who have a neurological or structural disorder which would impact use of exercise equipment; this will be determined by the physical therapist by assessing whether a neurological disorder or musculoskeletal disorder would prevent the patient from safely exercising
  • Any patient who, in the opinion of the investigators, will be unable to comply with a supervised exercise regimen
  • Any concurrent co-morbid illness and/or infection which in the opinion of the investigators could make the patient unable to comply fully with the trial procedures

Information from the National Library of Medicine

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


Contacts
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Contact: Valerae O. Lewis, BS,MD 713-745-4117 volewis@mdanderson.org

Locations
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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         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Valerae O Lewis M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02893397     History of Changes
Other Study ID Numbers: 2016-0411
NCI-2016-01969 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0411 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Bone Neoplasms
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases