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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

Tracking Information
First Submitted Date  ICMJE May 18, 2021
First Posted Date  ICMJE June 10, 2021
Last Update Posted Date June 10, 2021
Actual Study Start Date  ICMJE April 30, 2021
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2021)
  • Percent necrosis of tumor [ Time Frame: During surgery ]
    Percent necrosis at the time of tumor resection
  • 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.
  • 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.
  • 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.
  • Tissue Perfusion [ Time Frame: 6-week post-op ]
    Tissue Perfusion using the Near Infra-Red (NIRS) system
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise and Soft Tissue Sarcoma
Official Title  ICMJE The Effect of Exercise on Patient Outcomes During Treatment of Soft Tissue Sarcoma With Neoadjuvant Radiation Therapy and Surgical Resection
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Soft Tissue Sarcoma
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: neoadjuvant exercise therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2021)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2023
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elizabeth Sachs, MS 919-660-9849 elizabeth.sachs@duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04921917
Other Study ID Numbers  ICMJE Pro00093033
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE University of North Carolina, Chapel Hill
Investigators  ICMJE
Principal Investigator: William Eward, DVM, MD Duke Orthopedic Oncology
PRS Account Duke University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP