NCT04921917Recruiting
Exercise and Soft Tissue Sarcoma
The Effect of Exercise on Patient Outcomes During Treatment of Soft Tissue Sarcoma With Neoadjuvant Radiation Therapy and Surgical Resection
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 18 May 2021
- Start date
- 30 Apr 2021
- Primary completion date
- 1 Jan 2030
- Lead sponsor
- Duke University
- Diseases
- Sarcoma
- NCT number
- NCT04921917
What you commit to
- Study type: Interventional
- Planned participants: 24
- From 30 Apr 2021 to the primary completion date, 1 Jan 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)
Age
- Patients under the age of 18, or over the age of 85
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.