The Effect of Exercise on Patient Outcomes During Treatment of Soft Tissue Sarcoma With Neoadjuvant Radiation Therapy and Surgical Resection

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to evaluate the effect of a neoadjuvant (i.e. pre-treatment) exercise regimen on extremity function and postoperative wound healing. The study group will include patients with a primary diagnosis of soft tissue sarcoma undergoing treatment with neoadjuvant radiation therapy and surgical resection. Patients with upper or lower extremity sarcomas will be considered for enrollment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Males and females within the ages of 18-85

• Diagnosis of soft tissue sarcoma that has been histologically confirmed by an approved reference pathologist

• Sarcoma of the upper or lower extremity location

• Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection

• Expected primary wound closure performed at the time at surgery

• Any disease stage

• Any tumor grade

• Any histologic subtype

• First or recurrent presentations

⁃ No vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity

⁃ No history of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied

⁃ Must be able to comply with follow up visits

⁃ Must be able to provide own consent

Locations
United States
North Carolina
Duke University
RECRUITING
Durham
Contact Information
Primary
Elizabeth Sachs, MS
elizabeth.sachs@duke.edu
919-660-9849
Time Frame
Start Date: 2021-04-30
Estimated Completion Date: 2030-01-01
Participants
Target number of participants: 24
Treatments
No_intervention: Control
Standard of care: neoadjuvant radiation therapy (NRT).
Experimental: Neoadjuvant Exercise Regimen
Subjects will receive conventional NRT in conjunction with a prescribed exercise regimen during the usual 10-week duration of NRT treatment prior to tumor resection.
Related Therapeutic Areas
Sponsors
Leads: Duke University
Collaborators: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov