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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Standard of care: neoadjuvant radiation therapy (NRT). | |
| Neoadjuvant Exercise Regimen | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neoadjuvant exercise therapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 weeks post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Percent necrosis of tumor | Percent necrosis at the time of tumor resection | During surgery |
| Number of inflammatory serum markers | Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Sachs, MS | Contact | 919-660-9849 | elizabeth.sachs@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| William Eward, DVM, MD | Duke Orthopedic Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Recruiting | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001519 | Behavior |
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This study is partially blinded. The wound surveyor and statistician(s) will be blinded to the treatment groups.
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| First day of NRT |
| Number of inflammatory serum markers | Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR. | 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. | Last day of NRT (up to 10 weeks of NRT) |
| Tissue Perfusion | Tissue Perfusion using the Near Infra-Red (NIRS) system | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to 24 weeks post-op |