Soft Tissue SarcomaNCT04921917
Exercise and Soft Tissue Sarcoma
A study testing neoadjuvant exercise therapy in people with Soft Tissue Sarcoma, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- neoadjuvant exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2021to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27710
William Eward, DVM, MD, 919-613-5550, william.eward@duke.edu
About this study
Official title: The Effect of Exercise on Patient Outcomes During Treatment of Soft Tissue Sarcoma With Neoadjuvant Radiation Therapy and Surgical Resection
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.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- neoadjuvant exercise therapy
- Keywords
- exercise, soft tissue sarcoma, STS
- Medical subject headings
- Sarcoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant exercise therapyOther
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 group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard of care: neoadjuvant radiation therapy (NRT). |
| Neoadjuvant Exercise Regimen | Experimental | 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. Receives: Other: neoadjuvant exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 weeks post-op
Secondary outcomes (12)
Percent necrosis of tumor
Percent necrosis at the time of tumor resection
Measured: During surgery
Number of inflammatory serum markers
Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.
Measured: First day of NRT
Number of inflammatory serum markers
Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.
Measured: Halfway through NRT (up to 5 weeks of NRT)
Number of inflammatory serum markers
Number of inflammatory serum markers as assessed by CRP, Complete Blood Count, and ESR.
Measured: Last day of NRT (up to 10 weeks of NRT)
Tissue Perfusion
Tissue Perfusion using the Near Infra-Red (NIRS) system
Measured: 6-week post-op
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.
Measured: At enrollment.
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.
Measured: 2 weeks or less prior to surgery
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.
Measured: 6-week post-op
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.
Measured: At enrollment
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.
Measured: 2 weeks or less prior to surgery
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.
Measured: 6-week post-op
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.
Measured: Up to 24 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start30 Apr 2021
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- William Eward, DVM, MD, Principal investigator, Duke Orthopedic Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921917
- Sponsor's protocol ID
- Pro00093033
- Status last verified
- Apr 2026
- First submitted
- 18 May 2021
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise on Patient Outcomes During Treatment of Soft Tissue Sarcoma With Neoadjuvant Radiation Therapy and Surgical Resection
- ClinicalTrials.gov ID
- NCT04921917
- Acronym / sponsor ID
- Pro00093033
- Conditions
- Soft Tissue Sarcoma
- Keywords
- exercise, soft tissue sarcoma, STS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care: neoadjuvant radiation therapy (NRT). |
| Neoadjuvant Exercise Regimen | Experimental | Other: neoadjuvant exercise therapySubjects will receive conventional NRT in conjunction with a prescribed exercise regimen during the usual 10-week duration of NRT treatment prior to tumor resection. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neoadjuvant exercise therapybrief 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. | Other | Neoadjuvant Exercise Regimen |
Primary outcome
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.
12 secondary outcomes
Percent necrosis of tumor
Time frame: During surgery
Number of inflammatory serum markers
Time frame: First day of NRT
Number of inflammatory serum markers
Time frame: Halfway through NRT (up to 5 weeks of NRT)
Number of inflammatory serum markers
Time frame: Last day of NRT (up to 10 weeks of NRT)
Tissue Perfusion
Time frame: 6-week post-op
The Musculoskeletal Tumor Society (MSTS) score
Time frame: At enrollment.
The Musculoskeletal Tumor Society (MSTS) score
Time frame: 2 weeks or less prior to surgery
The Musculoskeletal Tumor Society (MSTS) score
Time frame: 6-week post-op
Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire
Time frame: At enrollment
Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire
Time frame: 2 weeks or less prior to surgery
Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire
Time frame: 6-week post-op
Surgical Wound Assessment Form
Time frame: Up to 24 weeks post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Eward, DVM, MD principal investigator
Duke Orthopedic Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neoadjuvant exercise therapy in people with Soft Tissue Sarcoma, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Sachs, MS (919-660-9849, elizabeth.sachs@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with a wound complication after surgery as measured by wound complication form (time frame: Up to 24 weeks post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.