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NCT Number: NCT04921917

Exercise and Soft Tissue Sarcoma

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.

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

William Eward, DVM, MD

CONTACT

[email protected]

919-613-5550

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females within the ages of 18-85
  • Diagnosis of soft tissue sarcoma that has been histologically confirmed by an approved reference pathologist
  • Sarcoma of the upper or lower extremity location
  • Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection
  • Expected primary wound closure performed at the time at surgery
  • Any disease stage
  • Any tumor grade
  • Any histologic subtype
  • First or recurrent presentations
  • No vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
  • No history of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
  • Must be able to comply with follow up visits
  • Must be able to provide own consent

Exclusion criteria

  • Patients under the age of 18, or over the age of 85
  • Treatment plan that does not include neo-adjuvant radiation and surgical excision
  • Sarcoma location other than the upper or lower extremity
  • History of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
  • High dose steroid therapy (defined as >5mg prednisone, or equivalent, with the last 30 days)
  • Active treatment with chemotherapy within the last 30 days
  • Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers)
  • Plan for post-operative radiation therapy
  • Underlying severe cardiopulmonary disease
  • Prior surgery, other than a biopsy, at the site of disease
  • Tumors that are ulcerative or fungating through the dermis at the time of presentation
  • Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
  • 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)
  • Actively uncontrolled diabetes mellitus (documentation of history of Diabetes with A1c>8)
  • Active deep vein thrombosis in the treatment extremity
  • Inability to comply with follow up visits
  • Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)

Treatment and study plan

neoadjuvant exercise therapy

Other

brief exercise regimen completed immediately prior to neoadjuvant radiation therapy. Rubber bands will be used for the exercise training of patients with lower extremity tumors while an electronic hand-held dynamometer will be used for the exercise training for patients with upper extremity tumors.

Primary outcomes

  1. Number of patients with a wound complication after surgery as measured by wound complication form

    Time frame: Up to 24 weeks post-op

    The wound complication form is a team developed form that asks about different complications that can arise after surgery. These complications include delayed wound healing, surgical site or periprosthetic infection, re-operation, and other invasive procedures necessitated by wound complications.

Secondary outcomes

  1. Percent necrosis of tumor

    Time frame: During surgery

    Percent necrosis at the time of tumor resection

  2. Number of inflammatory serum markers

    Time frame: First day of NRT

    Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.

  3. Number of inflammatory serum markers

    Time frame: Halfway through NRT (up to 5 weeks of NRT)

    Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.

  4. Number of inflammatory serum markers

    Time frame: Last day of NRT (up to 10 weeks of NRT)

    Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.

  5. Tissue Perfusion

    Time frame: 6-week post-op

    Tissue Perfusion using the Near Infra-Red (NIRS) system

  6. The Musculoskeletal Tumor Society (MSTS) score

    Time frame: At enrollment.

    The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function.

  7. The Musculoskeletal Tumor Society (MSTS) score

    Time frame: 2 weeks or less prior to surgery

    The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function.

  8. The Musculoskeletal Tumor Society (MSTS) score

    Time frame: 6-week post-op

    The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function.

  9. Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire

    Time frame: At enrollment

    The Edmonton Symptom Assessment System - Sarcoma Modified (ESAS-SM) questionnaire on quality of life. The total score ranges from 0 to 110, with lower scores indicating better quality of life.

  10. Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire

    Time frame: 2 weeks or less prior to surgery

    The Edmonton Symptom Assessment System - Sarcoma Modified (ESAS-SM) questionnaire on quality of life. The total score ranges from 0 to 110, with lower scores indicating better quality of life.

  11. Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire

    Time frame: 6-week post-op

    The Edmonton Symptom Assessment System - Sarcoma Modified (ESAS-SM) questionnaire on quality of life. The total score ranges from 0 to 110, with lower scores indicating better quality of life.

  12. Surgical Wound Assessment Form

    Time frame: Up to 24 weeks post-op

    Wound assessment and healing tracker tool created by the study team. The total score ranges from 13 to 65, with lower scores indicating better wound healing.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Sachs, MS

CONTACT

[email protected]

919-660-9849

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Jun 10, 2021
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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