| NCT ID | NCT04921917 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Soft Tissue Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2021-04-30 |
| Primary Completion | 2030-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2021-04-30 with a primary completion date of 2030-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
William Eward, DVM, MD
PRINCIPAL INVESTIGATOR
Duke Orthopedic Oncology
Frequently Asked Questions
Who can join the NCT04921917 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Soft Tissue Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04921917 currently recruiting?
Yes, NCT04921917 is actively recruiting participants. Contact the research team at elizabeth.sachs@duke.edu for enrollment information.
Where is the NCT04921917 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT04921917 clinical trial?
NCT04921917 is sponsored by Duke University. The principal investigator is William Eward, DVM, MD at Duke Orthopedic Oncology. The trial plans to enroll 24 participants.