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

NCT ID: NCT02893397

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-30
• Study Completion Date: 2026-08-30

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.

Conditions

Malignant Bone Neoplasm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: BEHAVIORAL

Undergo supervised exercise sessions

Group II (fitbit)

Patients wear a fitbit.

Group Type: EXPERIMENTAL

Activity Monitor

Intervention Type: DEVICE

Wear a fitbit

Interventions

Activity Monitor

Wear a fitbit

Intervention Type: DEVICE

Exercise Intervention

Undergo supervised exercise sessions

Intervention Type: BEHAVIORAL

Other Intervention Names

Activity Tracker; Activity Tracker Device; Physical Activity Measuring Device

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valerae O Lewis

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

NCI-2016-01969

Identifier Type: REGISTRY

Identifier Source: secondary_id

2016-0411

Identifier Type: OTHER

Identifier Source: secondary_id

2016-0411

Identifier Type: -

Identifier Source: org_study_id