Exercise and Soft Tissue Sarcoma

NCT ID: NCT04921917

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2030-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Standard of care: neoadjuvant radiation therapy (NRT).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Neoadjuvant Exercise Regimen

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.

Group Type: EXPERIMENTAL

neoadjuvant exercise therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Eward, DVM, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Orthopedic Oncology

Locations

Duke University

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth Sachs, MS

Role: CONTACT

elizabeth.sachs@duke.edu

919-660-9849

Facility Contacts

William Eward, DVM, MD

Role: primary

william.eward@duke.edu

919-613-5550

Other Identifiers

Pro00093033

Identifier Type: -

Identifier Source: org_study_id