Exercise and Soft Tissue Sarcoma

Last updated: April 15, 2025
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sarcoma

Sarcoma (Pediatric)

Soft Tissue Sarcoma

Treatment

neoadjuvant exercise therapy

Clinical Study ID

NCT04921917
Pro00093033
  • Ages 18-85
  • All Genders

Study 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

Inclusion Criteria:

  1. Males and females within the ages of 18-85

  2. Diagnosis of soft tissue sarcoma that has been histologically confirmed by anapproved reference pathologist

  3. Sarcoma of the upper or lower extremity location

  4. Treatment plan that includes neo-adjuvant radiation therapy followed by surgicalresection

  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 decreasedperfusion of the extremity

  11. No history of radiation therapy to the tumor and/or surgical area prior to thecurrent treatment being studied

  12. Must be able to comply with follow up visits

  13. Must be able to provide own consent

Exclusion

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 currenttreatment 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, cognitiveimpairment, 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 ofpresentation

  12. Vascular invasion or resection/repair/reconstruction that results in decreasedperfusion of the extremity

  13. Vascular disease resulting in clinically apparent compromise in blood flow to thetreatment extremity (i.e. peripheral vascular disease with diminished pulses, venousinsufficiency with clinical evidence of vascular congestion)

  14. Actively uncontrolled diabetes mellitus (documentation of history of Diabetes withA1c>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 serumpregnancy test prior to enrollment)

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: neoadjuvant exercise therapy
Phase:
Study Start date:
April 30, 2021
Estimated Completion Date:
January 01, 2030

Connect with a study center

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

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