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Tests exercise before treatment in adults with soft tissue sarcoma

Tests pre-treatment exercise in adults with sarcoma in an arm or leg.

Plain-language title generated from the registry record
Registry title: Exercise and Soft Tissue Sarcoma

Key facts

Where
Durham, United StatesSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 85 years old?

Source: NCT04921917, who can take part

Where in United States

  • Duke UniversityDurham, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Duke University
Trial code
NCT04921917
Record updated
8 April 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: Treatment plan that does not include neo-adjuvant radiation and surgical excision; 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; Plan for post-operative radiation therapy; Prior surgery, other than a biopsy, at the site of disease; Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity; Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers); Underlying severe cardiopulmonary disease; 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; Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment); Patients under the age of 18, or over the age of 85; Sarcoma location other than the upper or lower extremity; Tumors that are ulcerative or fungating through the dermis at the time of presentation; Inability to comply with follow up visits.

ClinicalTrials.gov NCT04921917