Exercise and Soft Tissue Sarcoma

Study Overview
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Brief Summary
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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.

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

Conditions
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Soft Tissue Sarcoma

Intervention / Treatment
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* Other: neoadjuvant exercise therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patients under the age of 18, or over the age of 85 Treatment plan that does not include neo-adjuvant radiation and surgical excision Sarcoma location other than the upper or lower extremity History of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied High dose steroid therapy (defined as >5mg prednisone, or equivalent, with the last 30 days) Active treatment with chemotherapy within the last 30 days Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers) Plan for post-operative radiation therapy Underlying severe cardiopulmonary disease Prior surgery, other than a biopsy, at the site of disease Tumors that are ulcerative or fungating through the dermis at the time of presentation Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity 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) Actively uncontrolled diabetes mellitus (documentation of history of Diabetes with A1c>8) Active deep vein thrombosis in the treatment extremity Inability to comply with follow up visits Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard of care: neoadjuvant radiation therapy (NRT). | |
| Experimental: Neoadjuvant Exercise Regimen<br>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. | Other: neoadjuvant exercise therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, soft tissue sarcoma, STS