Exercise and Soft Tissue Sarcoma

Description

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 Overview

Study Details

Study overview

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.

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

Exercise and Soft Tissue Sarcoma

Condition
Soft Tissue Sarcoma
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University, Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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)

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

William Eward, DVM, MD, PRINCIPAL_INVESTIGATOR, Duke Orthopedic Oncology

Study Record Dates

2030-01-01