Exercise and Soft Tissue Sarcoma

NCT04921917 | Recruiting DMC

• 1 other identifier: Pro00093033
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Sarcoma

Keywords

exercise; soft tissue sarcoma; STS

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 24 weeks post-op

Secondary Outcomes (12)

• Percent necrosis of tumor

  During surgery

• Number of inflammatory serum markers

  First day of NRT

• Number of inflammatory serum markers

  Halfway through NRT (up to 5 weeks of NRT)

• Number of inflammatory serum markers

  Last day of NRT (up to 10 weeks of NRT)

• Tissue Perfusion

  6-week post-op

Study Arms (2)

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.

Other: neoadjuvant exercise therapy

Interventions

neoadjuvant exercise therapy OTHER

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.

Neoadjuvant Exercise Regimen

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Sarcoma; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Behavior

Study Officials

• William Eward, DVM, MD

  Duke Orthopedic Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Sachs, MS

CONTACT

919-660-9849; elizabeth.sachs@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study is partially blinded. The wound surveyor and statistician(s) will be blinded to the treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: June 10, 2021
• Study Start: April 30, 2021
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)