Clinical trial NCT02893397: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Malignant Bone Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-09-08
Enrollment: 45
Sex: ALL
Minimum age (years): 5
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: 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
timeFrame: At least 4 weeks
Secondary outcomes:
measure: Change in tumor vascularity as measured by magnetic resonance imaging diffusion studies
timeFrame: Baseline up to 4 weeks
measure: Change in tumor vascularity as measured by blood serum analysis of serum thrombospondin-1 and sphingosine-1-phosphate
timeFrame: Baseline up to 4 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Valerae O Lewis
role: PRINCIPAL_INVESTIGATOR
References: