Duke University
Durham, North Carolina, 27710, United States
Location status: Recruiting
NCT Number: NCT04921917
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
Durham, North Carolina, 27710, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: During surgery
Percent necrosis at the time of tumor resection
Time frame: First day of NRT
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 as assessed by CRP, Complete Blood Count, and ESR.
Time frame: Last day of NRT (up to 10 weeks of NRT)
Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.
Time frame: 6-week post-op
Tissue Perfusion using the Near Infra-Red (NIRS) system
Time frame: 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.
Time frame: 2 weeks or less prior to surgery
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
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: 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.
Time frame: 2 weeks or less prior to surgery
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
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: 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.
Contact information is provided by the study sponsor or research team.
Duke University
Other
The Effect of Exercise on Patient Outcomes During Treatment of Soft Tissue Sarcoma With Neoadjuvant Radiation Therapy and Surgical Resection
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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