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

Malignant Bone Neoplasm Clinical Trial

Official title:

Pre-Surgical Supervised Exercise for Bone Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02893397
• Other study ID #: 2016-0411
• Secondary ID: NCI-2016-0196920
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 30, 2016
• Est. completion date: August 30, 2024

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Neoplasms
• Malignant Bone Neoplasm

Intervention

Device:
• Activity Monitor
Wear a fitbit

Behavioral:
• Exercise Intervention
Undergo supervised exercise sessions

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas
United States	Texas Children's Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At least 4 weeks
Secondary	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.	Baseline up to 4 weeks
Secondary	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.	Baseline up to 4 weeks

External Links

•   MD Anderson Cancer Center