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Exercise and Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT04921917
Recruitment Status : Recruiting
First Posted : June 10, 2021
Last Update Posted : June 10, 2021
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Other: neoadjuvant exercise therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: This study is partially blinded. The wound surveyor and statistician(s) will be blinded to the treatment groups.
Primary Purpose: Treatment
Official Title: The Effect of Exercise on Patient Outcomes During Treatment of Soft Tissue Sarcoma With Neoadjuvant Radiation Therapy and Surgical Resection
Actual Study Start Date : April 30, 2021
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023


Arm Intervention/treatment
No Intervention: Control
Standard of care: neoadjuvant radiation therapy (NRT).
Experimental: Neoadjuvant Exercise Regimen
Subjects will receive conventional NRT in conjunction with a prescribed exercise regimen during the usual 10-week duration of NRT treatment prior to tumor resection.
Other: neoadjuvant exercise therapy
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 Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04921917


Contacts
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Contact: Elizabeth Sachs, MS 919-660-9849 elizabeth.sachs@duke.edu

Locations
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United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: William Eward, DVM, MD    919-613-5550    william.eward@duke.edu   
Sponsors and Collaborators
Duke University
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: William Eward, DVM, MD Duke Orthopedic Oncology
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04921917    
Other Study ID Numbers: Pro00093033
First Posted: June 10, 2021    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
exercise
soft tissue sarcoma
STS
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms