Recruiting

Exercise

Sponsor:

Duke University

Code:

NCT04921917

Conditions

Soft Tissue Sarcoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

neoadjuvant exercise therapy

Study Details

Brief summary:

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.

Conditions

Soft Tissue Sarcoma

Study ID

NCT04921917

Start date

Apr 30, 2021

Status verified date

Apr, 2026

Completion date

Jan 1, 2030

Anticipated

Primary completion date

Jan 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Males and females within the ages of 18-85
2. Diagnosis of soft tissue sarcoma that has been histologically confirmed by an approved reference pathologist
3. Sarcoma of the upper or lower extremity location
4. Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection
5. Expected primary wound closure performed at the time at surgery
6. Any disease stage
7. Any tumor grade
8. Any histologic subtype
9. First or recurrent presentations
10. No vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
11. No history of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
12. Must be able to comply with follow up visits
13. Must be able to provide own consent

Exclusion Criteria:

1. Patients under the age of 18, or over the age of 85
2. Treatment plan that does not include neo-adjuvant radiation and surgical excision
3. Sarcoma location other than the upper or lower extremity
4. History of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
5. High dose steroid therapy (defined as >5mg prednisone, or equivalent, with the last 30 days)
6. Active treatment with chemotherapy within the last 30 days
7. Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers)
8. Plan for post-operative radiation therapy
9. Underlying severe cardiopulmonary disease
10. Prior surgery, other than a biopsy, at the site of disease
11. Tumors that are ulcerative or fungating through the dermis at the time of presentation
12. Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
13. 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)
14. Actively uncontrolled diabetes mellitus (documentation of history of Diabetes with A1c>8)
15. Active deep vein thrombosis in the treatment extremity
16. Inability to comply with follow up visits
17. Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

Standard of care: neoadjuvant radiation therapy (NRT).

experimental: Neoadjuvant Exercise Regimen

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.

Interventions

neoadjuvant exercise therapy

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.

Primary outcome measure

  • Number of patients with a wound complication after surgery as measured by wound complication form [ Time Frame: Up to 24 weeks post-op ]

Central Contacts and Locations

Central contacts

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

More Information

Sponsor

Duke University

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • exercise
  • soft tissue sarcoma
  • STS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-04-08.