Image

Exercise and Soft Tissue Sarcoma

Exercise and Soft Tissue Sarcoma

Recruiting
18-85 years
All
Phase N/A

Powered by AI

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.

Eligibility

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 details
    Soft Tissue Sarcoma

NCT04921917

Duke University

27 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.