Effect of Exercise on Patient Outcomes in Patients with Soft Tissue Sarcoma during Treatment with Neoadjuvant Radiation Therapy and Surgical Resection
This trial studies the effects of a preoperative exercise regimen on extremity function and wound healing in patients with soft tissue sarcoma undergoing surgical resection with radiation therapy. This may provide information on how to lower the risk of wound complications and improve patient outcomes after surgical resection.
Inclusion Criteria
- 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
- 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 > 5 mg 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 mellitus [DM] 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)
Additional locations may be listed on ClinicalTrials.gov for NCT04921917.
Locations matching your search criteria
United States
North Carolina
Durham
PRIMARY OBJECTIVES:
I. To compare the percent necrosis of the tumor and inflammatory serum markers (CRP, IL-6, IL-8, and IL-10) between patients who received neoadjuvant exercise therapy along with neoadjuvant radiation therapy and those who only received neoadjuvant radiation therapy.
II. To compare tissue perfusion and oxygenation using near infrared spectroscopy (NIRS), a real-time system that permits assessment of changes in oxy-haemoglobin and deoxy-haemoglobin in a specific region/muscle (tumor site) between patients with soft tissue sarcoma receiving neoadjuvant exercise therapy along with neoadjuvant radiation therapy and those only receiving neoadjuvant radiation therapy.
III. To compare extremity function through the Musculoskeletal Tumor Society (MSTS) score between patients with soft tissue sarcoma receiving neoadjuvant exercise therapy along with neoadjuvant radiation therapy and those only receiving neoadjuvant radiation therapy.
IV. To compare the quality of life score through the Edmonton Symptom Assessment System - Sarcoma Modified (ESAS-SM) questionnaire between patients with soft tissue sarcoma receiving neoadjuvant exercise therapy along with neoadjuvant radiation therapy and those only receiving neoadjuvant radiation therapy.
V. To compare the incidence of wound complications and wound healing in the weeks following surgery between patients with soft tissue sarcoma receiving neoadjuvant exercise therapy along with neoadjuvant radiation therapy and those only receiving neoadjuvant radiation therapy.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo neoadjuvant radiation therapy per standard care over 10 weeks. Patients then undergo surgical excision of tumor.
GROUP II: Patients undergo neoadjuvant radiation therapy per standard care and receive exercise training over 10 weeks. Patients then undergo surgical excision of tumor.
After completion of study treatment, patients are followed up at 3, 6, 12, and 24 weeks and then up to 12 months following surgery completion.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDuke University Medical Center
Principal InvestigatorWilliam Eward
- Primary IDPro00093033
- Secondary IDsNCI-2020-01389
- ClinicalTrials.gov IDNCT04921917