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

Pre-Surgical Supervised Exercise for Bone Cancer Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malignant Bone Neoplasm
• Intervention / Treatment: Behavioral: Exercise Intervention; Device: Activity Monitor

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 39 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Valerae O Lewis, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2016
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: August 31, 2016
• First Submitted That Met QC Criteria: September 2, 2016
• First Posted (Estimated): September 8, 2016

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Bone Diseases; Bone Neoplasms
• Other Study ID Numbers: 2016-0411 (Other Identifier: M D Anderson Cancer Center); NCI-2016-01969 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No