Exercise and Soft Tissue Sarcoma
Primary Purpose
Soft Tissue Sarcoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
neoadjuvant exercise therapy
Sponsored by
About this trial
This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring exercise, soft tissue sarcoma, STS
Eligibility Criteria
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)
Sites / Locations
- Duke UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Neoadjuvant Exercise Regimen
Arm Description
Standard of care: neoadjuvant radiation therapy (NRT).
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.
Outcomes
Primary Outcome Measures
Number of patients with a wound complication after surgery as measured by wound complication form
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
Percent necrosis of tumor
Percent necrosis at the time of tumor resection
Number of inflammatory serum markers
Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.
Number of inflammatory serum markers
Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.
Number of inflammatory serum markers
Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.
Tissue Perfusion
Tissue Perfusion using the Near Infra-Red (NIRS) system
The Musculoskeletal Tumor Society (MSTS) score
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
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
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
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
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
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
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.
Full Information
NCT ID
NCT04921917
First Posted
May 18, 2021
Last Updated
May 11, 2023
Sponsor
Duke University
Collaborators
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT04921917
Brief Title
Exercise and Soft Tissue Sarcoma
Official Title
The Effect of Exercise on Patient Outcomes During Treatment of Soft Tissue Sarcoma With Neoadjuvant Radiation Therapy and Surgical Resection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
University of North Carolina, Chapel Hill
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma
Keywords
exercise, soft tissue sarcoma, STS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
This study is partially blinded. The wound surveyor and statistician(s) will be blinded to the treatment groups.
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care: neoadjuvant radiation therapy (NRT).
Arm Title
Neoadjuvant Exercise Regimen
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
neoadjuvant exercise therapy
Intervention Description
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 Measure Information:
Title
Number of patients with a wound complication after surgery as measured by wound complication form
Description
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.
Time Frame
Up to 24 weeks post-op
Secondary Outcome Measure Information:
Title
Percent necrosis of tumor
Description
Percent necrosis at the time of tumor resection
Time Frame
During surgery
Title
Number of inflammatory serum markers
Description
Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.
Time Frame
First day of NRT
Title
Number of inflammatory serum markers
Description
Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.
Time Frame
Halfway through NRT (up to 5 weeks of NRT)
Title
Number of inflammatory serum markers
Description
Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.
Time Frame
Last day of NRT (up to 10 weeks of NRT)
Title
Tissue Perfusion
Description
Tissue Perfusion using the Near Infra-Red (NIRS) system
Time Frame
6-week post-op
Title
The Musculoskeletal Tumor Society (MSTS) score
Description
The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function.
Time Frame
At enrollment.
Title
The Musculoskeletal Tumor Society (MSTS) score
Description
The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function.
Time Frame
2 weeks or less prior to surgery
Title
The Musculoskeletal Tumor Society (MSTS) score
Description
The Musculoskeletal Tumor Society (MSTS) score of extremity function. The total score ranges from 0 to 30, with higher scores indicating better function.
Time Frame
6-week post-op
Title
Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire
Description
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.
Time Frame
At enrollment
Title
Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire
Description
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.
Time Frame
2 weeks or less prior to surgery
Title
Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire
Description
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.
Time Frame
6-week post-op
Title
Surgical Wound Assessment Form
Description
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.
Time Frame
Up to 24 weeks post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Sachs, MS
Phone
919-660-9849
Email
elizabeth.sachs@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Eward, DVM, MD
Organizational Affiliation
Duke Orthopedic Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Eward, DVM, MD
Phone
919-613-5550
Email
william.eward@duke.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Exercise and Soft Tissue Sarcoma
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