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Supervised Exercise in Improving Physical Fitness Before Surgery in Patients With Resectable Bone Cancer

Primary Purpose

Malignant Bone Neoplasm

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Activity Monitor
Exercise Intervention
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malignant Bone Neoplasm

Eligibility Criteria

5 Years - 39 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group I (supervised exercise)

Group II (fitbit)

Arm Description

Patients wear a fitbit and undergo supervised physical therapy exercise sessions over 40 minutes 3-5 times a week for at least 4 weeks.

Patients wear a fitbit.

Outcomes

Primary Outcome Measures

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
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

Change in tumor vascularity as measured by magnetic resonance imaging diffusion studies
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
Will use a two-sided t-test with a significance level of 5% to compare the tumor vascularity between groups.

Full Information

First Posted
August 31, 2016
Last Updated
October 2, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02893397
Brief Title
Supervised Exercise in Improving Physical Fitness Before Surgery in Patients With Resectable Bone Cancer
Official Title
Pre-Surgical Supervised Exercise for Bone Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 30, 2016 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Bone Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (supervised exercise)
Arm Type
Experimental
Arm Description
Patients wear a fitbit and undergo supervised physical therapy exercise sessions over 40 minutes 3-5 times a week for at least 4 weeks.
Arm Title
Group II (fitbit)
Arm Type
Experimental
Arm Description
Patients wear a fitbit.
Intervention Type
Device
Intervention Name(s)
Activity Monitor
Other Intervention Name(s)
Activity Tracker, Activity Tracker Device, Physical Activity Measuring Device
Intervention Description
Wear a fitbit
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Undergo supervised exercise sessions
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
At least 4 weeks
Secondary Outcome Measure Information:
Title
Change in tumor vascularity as measured by magnetic resonance imaging diffusion studies
Description
Will use a two-sided t-test with a significance level of 5% to compare the tumor vascularity between groups.
Time Frame
Baseline up to 4 weeks
Title
Change in tumor vascularity as measured by blood serum analysis of serum thrombospondin-1 and sphingosine-1-phosphate
Description
Will use a two-sided t-test with a significance level of 5% to compare the tumor vascularity between groups.
Time Frame
Baseline up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerae O Lewis
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

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Supervised Exercise in Improving Physical Fitness Before Surgery in Patients With Resectable Bone Cancer

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