The Effect of Exercise on Patient Outcomes During Treatment of Soft Tissue Sarcoma With Neoadjuvant Radiation Therapy and Surgical Resection
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.
Arms & interventions
- Otherneoadjuvant exercise therapy
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.
Outcome measures
Primary
Number 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
Secondary
Percent necrosis of tumor
Time frame: During surgery
Number of inflammatory serum markers
Time frame: First day of NRT
Number of inflammatory serum markers
Time frame: Halfway through NRT (up to 5 weeks of NRT)
Number of inflammatory serum markers
Time frame: Last day of NRT (up to 10 weeks of NRT)
Tissue Perfusion
Time frame: 6-week post-op
The Musculoskeletal Tumor Society (MSTS) score
Time frame: At enrollment.
The Musculoskeletal Tumor Society (MSTS) score
Time frame: 2 weeks or less prior to surgery
The Musculoskeletal Tumor Society (MSTS) score
Time frame: 6-week post-op
Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire
Time frame: At enrollment
Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire
Time frame: 2 weeks or less prior to surgery
Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire
Time frame: 6-week post-op
Surgical Wound Assessment Form
Time frame: Up to 24 weeks post-op
Eligibility criteria
Study locations (1)
Duke University
Durham, North Carolina, 27710