Recruiting NCT04921917
Exercise and Soft Tissue Sarcoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: neoadjuvant exercise therapy.
- Who it may be relevant to
- Registry conditions: Soft Tissue Sarcoma. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Exercise on Patient Outcomes During Treatment of Soft Tissue Sarcoma With Neoadjuvant Radiation Therapy and Surgical Resection
Overview
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.
Interventions
- 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
- Number of patients with a wound complication after surgery as measured by wound complication form [Time frame: Up to 24 weeks post-op]
Secondary outcome measures (12)
- 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]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke University — Durham
Identifiers
NCT: NCT04921917 · Pro00093033