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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
brief exercise regimen completed immediately prior to neoadjuvant radiation therapy. Rubber bands will be used for the exercise training of patients with lower extremity tumors while an electronic hand-held dynamometer will be used for the exercise training for patients with upper extremity tumors.
Duke University
Durham, North Carolina, United States
RECRUITINGNumber of patients with a wound complication after surgery as measured by wound complication form
The wound complication form is a team developed form that asks about different complications that can arise after surgery. These complications include delayed wound healing, surgical site or periprosthetic infection, re-operation, and other invasive procedures necessitated by wound complications.
Time frame: Up to 24 weeks post-op
Percent necrosis of tumor
Percent necrosis at the time of tumor resection
Time frame: During surgery
Number of inflammatory serum markers
Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.
Time frame: First day of NRT
Number of inflammatory serum markers
Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.
Time frame: Halfway through NRT (up to 5 weeks of NRT)
Number of inflammatory serum markers
Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.
Time frame: Last day of NRT (up to 10 weeks of NRT)
Tissue Perfusion
Tissue Perfusion using the Near Infra-Red (NIRS) system
Time frame: 6-week post-op
The Musculoskeletal Tumor Society (MSTS) score
The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: At enrollment.
The Musculoskeletal Tumor Society (MSTS) score
The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function.
Time frame: 2 weeks or less prior to surgery
The Musculoskeletal Tumor Society (MSTS) score
The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function.
Time frame: 6-week post-op
Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire
The Edmonton Symptom Assessment System - Sarcoma Modified (ESAS-SM) questionnaire on quality of life. The total score ranges from 0 to 110, with lower scores indicating better quality of life.
Time frame: At enrollment
Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire
The Edmonton Symptom Assessment System - Sarcoma Modified (ESAS-SM) questionnaire on quality of life. The total score ranges from 0 to 110, with lower scores indicating better quality of life.
Time frame: 2 weeks or less prior to surgery
Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire
The Edmonton Symptom Assessment System - Sarcoma Modified (ESAS-SM) questionnaire on quality of life. The total score ranges from 0 to 110, with lower scores indicating better quality of life.
Time frame: 6-week post-op
Surgical Wound Assessment Form
Wound assessment and healing tracker tool created by the study team. The total score ranges from 13 to 65, with lower scores indicating better wound healing.
Time frame: Up to 24 weeks post-op