Clinical trial NCT04921917: 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
Overall status: RECRUITING
Phase: NA
Conditions: Soft Tissue Sarcoma
Keywords: exercise
soft tissue sarcoma
STS
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2021-06-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Number of patients with a wound complication after surgery as measured by wound complication form
timeFrame: Up to 24 weeks post-op
Secondary outcomes:
measure: Percent necrosis of tumor
timeFrame: During surgery
measure: Number of inflammatory serum markers
timeFrame: First day of NRT
measure: Number of inflammatory serum markers
timeFrame: Halfway through NRT (up to 5 weeks of NRT)
measure: Number of inflammatory serum markers
timeFrame: Last day of NRT (up to 10 weeks of NRT)
measure: Tissue Perfusion
timeFrame: 6-week post-op
measure: The Musculoskeletal Tumor Society (MSTS) score
timeFrame: At enrollment.
measure: The Musculoskeletal Tumor Society (MSTS) score
timeFrame: 2 weeks or less prior to surgery
measure: The Musculoskeletal Tumor Society (MSTS) score
timeFrame: 6-week post-op
measure: Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire
timeFrame: At enrollment
measure: Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire
timeFrame: 2 weeks or less prior to surgery
measure: Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire
timeFrame: 6-week post-op
measure: Surgical Wound Assessment Form
timeFrame: Up to 24 weeks post-op
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke Orthopedic Oncology
name: William Eward, DVM, MD
role: PRINCIPAL_INVESTIGATOR
References: