Exercise program for patients with soft tissue sarcoma

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

This study tests if an exercise program before surgery can help patients with soft tissue sarcoma recover better and heal faster after treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Duke University (other)
• Drugs / interventions: chemotherapy, radiation, prednisone
• Locations: 1 site (Durham, North Carolina)
• Trial ID: NCT04921917 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of a pre-treatment exercise regimen on extremity function and postoperative wound healing in patients diagnosed with soft tissue sarcoma. Participants will undergo neoadjuvant radiation therapy followed by surgical resection, and the study aims to assess how exercise influences recovery outcomes. The focus is on patients with sarcomas located in the upper or lower extremities, and the study will monitor their progress through follow-up visits.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 with a confirmed diagnosis of soft tissue sarcoma in the upper or lower extremities who are scheduled for neoadjuvant radiation therapy and surgical resection.

Not a fit: Patients under 18 or over 85, or those whose treatment plans do not include neoadjuvant radiation and surgical excision, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance recovery and improve functional outcomes for patients undergoing treatment for soft tissue sarcoma.

How similar studies have performed: While the specific approach of combining exercise with neoadjuvant treatment for soft tissue sarcoma is novel, similar studies in other cancer types have shown positive outcomes.

Eligibility criteria

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)

Where this trial is running

Durham, North Carolina

• Duke University — Durham, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: William Eward, DVM, MD — Duke Orthopedic Oncology
• Study coordinator: Elizabeth Sachs, MS

Conditions: Soft Tissue Sarcoma, exercise, soft tissue sarcoma, STS