2022-09-27
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v10
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2022-08-02
minor
Study Identification, Study Status, References v9
Primary completion date2020-08-30→2024-08-30
Completion date2021-08-30→2024-08-30
2019-06-10
minor
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v7
Primary completion date2020-08→2020-08-30
Completion date2021-08→2021-08-30
Start date2016-08→2016-08-30
Enrollment target30→45
InterventionsSupervised Exercise Program (Behavioral)→Activity Monitor (Device), Exercise Intervention (Behavioral)
Eligibility criteria-16 characters
Inclusion Criteria:
Patients must be equal to or greater than 5 years of age and less than 39 years of age at the time of enrollment
Patients must have a new diagnosis of Osteosarcoma or Ewing's sarcoma ofprimary bone.
Both maletumor, and femalewhose patientstreatment areplan eligibleincludes surgery
Patients who are receivingexpected to receive at least 4 weeks of neoadjuvant chemotherapy treatment atbetween UTenrollment MDin Andersonthe Cancerstudy Center.and planned surgery
Participants willing to wear a Fitbit
Exclusion Criteria:
Patients who are not receiving their primary cancer care (su [...] [...]
Secondary endpoints+205 characters
Change in tumor vascularity as measured by magnetic resonance imaging diffusion studies
Change in tumor vascularity as measured by blood serum analysis of serum thrombospondin-1 and sphingosine-1-phosphate
Primary endpoints1 entry, revised
PercentageFeasibility Participantsdefined Completingas Dailyat Exerciseleast 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
Study description-1,606 characters
StudyPRIMARY GroupsOBJECTIVES:
IfI. youTo agreedetermine 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 [...] to takechildren partand 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 malignan [...] [...]
Study sites1 entry, revised
TheM University of Texas MDD Anderson Cancer Center
Collaborators+31 characters
National Cancer Institute (NCI)
Study title+47 characters
Pre-Surgical Supervised Exercise forin Improving Physical Fitness Before Surgery in Patients With Resectable Bone Cancer Patients
2018-03-21
minor
Study Status, Oversight v4
Primary completion date2019-08→2020-08
Completion date2019-08→2021-08
2017-05-10
minor
Study Identification, Study Status, Study Description v2
Completion datenot stated→2019-08
Study description+70 characters
Study Groups:
If theyyou agree to take part in this study, theyyou will be assigned to 1 of 2 groups based on theiryour availability and if theyyou live within 25 miles of MD Anderson:
If theyyou are in Group 1, theyyou will take part in a supervised exercise program.
If theyyou are in Group 2, theyyou will not take part in the exercise program.
Length of Study Participation No matter which group theyyou are in, theiryour participation in this study will be over after theyyou complete theiryour chemotherapy and before surgery.
Study Visits:
For All Participants:
At the Beginning of the Study:
[...]
2016-09-08
minor
Study Status, Contacts/Locations v1
Re-verified, no change to tracked fields