Soft Tissue Sarcoma
Conditions
Keywords
exercise, soft tissue sarcoma, STS
Brief 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.
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.
Sponsors
Duke University
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
This study is partially blinded. The wound surveyor and statistician(s) will be blinded to the treatment groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females within the ages of 18-85 2. Diagnosis of soft tissue sarcoma that has been histologically confirmed by an approved reference pathologist 3. Sarcoma of the upper or lower extremity location 4. Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection 5. Expected primary wound closure performed at the time at surgery 6. Any disease stage 7. Any tumor grade 8. Any histologic subtype 9. First or recurrent presentations 10. No vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity 11. No history of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied 12. Must be able to comply with follow up visits 13. Must be able to provide own consent
Exclusion criteria
1. Patients under the age of 18, or over the age of 85 2. Treatment plan that does not include neo-adjuvant radiation and surgical excision 3. Sarcoma location other than the upper or lower extremity 4. History of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied 5. High dose steroid therapy (defined as \>5mg prednisone, or equivalent, with the last 30 days) 6. Active treatment with chemotherapy within the last 30 days 7. Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers) 8. Plan for post-operative radiation therapy 9. Underlying severe cardiopulmonary disease 10. Prior surgery, other than a biopsy, at the site of disease 11. Tumors that are ulcerative or fungating through the dermis at the time of presentation 12. Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity 13. Vascular disease resulting in clinically apparent compromise in blood flow to the treatment extremity (i.e. peripheral vascular disease with diminished pulses, venous insufficiency with clinical evidence of vascular congestion) 14. Actively uncontrolled diabetes mellitus (documentation of history of Diabetes with A1c\>8) 15. Active deep vein thrombosis in the treatment extremity 16. Inability to comply with follow up visits 17. Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with a wound complication after surgery as measured by wound complication form | Up to 24 weeks post-op | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent necrosis of tumor | During surgery | Percent necrosis at the time of tumor resection |
| Number of inflammatory serum markers | First day of NRT | Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR. |
| Tissue Perfusion | 6-week post-op | Tissue Perfusion using the Near Infra-Red (NIRS) system |
| The Musculoskeletal Tumor Society (MSTS) score | At enrollment. | The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function. |
| Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire | At enrollment | 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. |
| Surgical Wound Assessment Form | Up to 24 weeks post-op | 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. |
Countries
United States
Contacts
CONTACTElizabeth Sachs, MS
PRINCIPAL_INVESTIGATORWilliam Eward, DVM, MD
Duke Orthopedic Oncology
Outcome results
None listed