The Effect of Exercise on Patient Outcomes During Treatment of Soft Tissue Sarcoma With Neoadjuvant Radiation Therapy and Surgical Resection

Duke University1 site in 1 country24 target enrollmentApril 30, 2021

ConditionsSoft Tissue Sarcoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Soft Tissue Sarcoma
Sponsor: Duke University
Enrollment: 24
Locations: 1
Primary Endpoint: Number of patients with a wound complication after surgery as measured by wound complication form
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 30, 2021

End Date

January 1, 2030

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Duke University

Responsible Party

Sponsor

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

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Number of inflammatory serum markers(Last day of NRT (up to 10 weeks of NRT))
Tissue Perfusion(6-week post-op)
The Musculoskeletal Tumor Society (MSTS) score(6-week post-op)
Percent necrosis of tumor(During surgery)
Edmonton Symptom Assessment System (ESAS) - Sarcoma Modified (SM) quality of life questionnaire(6-week post-op)
Surgical Wound Assessment Form(Up to 24 weeks post-op)