NCT05526417

Individualized Prehabilitation for Enhancing Recovery and Surgical Outcomes in Patients Undergoing Radiotherapy and Surgery for Soft Tissue Sarcoma

Pre-Operative ERAS® (Enhanced Recovery After Surgery): Randomized Feasibility Trial of Implementing Individualized Prehabilitation for People Undergoing Neo-Adjuvant Radiotherapy and Lower Limb Soft-Tissue Sarcoma Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial evaluates whether patients with deep soft tissue sarcomas who receive a tailored prehabilitation exercise regimen during standard radiotherapy and prior to standard of care surgery have better recovery and surgical outcomes than those who do not. Patients undergoing surgery to soft tissue sarcomas are at high risk for post-operative disability, which is associated with high rates of depression and poor health-related quality of life. Prehabilitation is the practice of exercising before surgery to ensure that the patient is in the best possible condition. It allows patients to prepare their bodies for recovery after surgery, which may result in better surgical outcomes, recovery, and quality of life after surgery.

Detailed description

PRIMARY OBJECTIVES: I. To determine if a tailored prehabilitation program focusing on functional optimization of spared limb tissue in two groups of patients with localized, lower extremity soft tissue sarcoma, one with prehabilitation and one with equal attention and informational support, improves functional outcome as measure by the Toronto Extremity Salvage Score (TESS). II. To identify the measures and metrics most responsive to the intervention using the (TESS), Six Minute Walk Test (6MWT), wearable Heel2Toe sensor technology, and daily step count. III. To estimate recruitment, retention, adherence, and acceptability rates. SECONDARY OBJECTIVES: I. To compare changes in quality of life over time as a result of the prehabilitation intervention using the Edmonton Symptom Assessment Scale (ESAS), European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L) (Euroqol Group), the Patient Generated Index (PGI). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients perform personalized prehabilitation physical therapy exercises twice a day (BID) 5 days per week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery, attend telemedicine visits with a physical therapist once a week for 9 weeks, and receive educational materials. Patients undergo magnetic resonance imaging (MRI) and computed tomography (CT) at week 9. ARM II: Patients receive educational materials and attend a telemedicine visit with a research assistant once a week for 8 weeks while receiving standard of care radiotherapy prior to standard of care surgery. Patients undergo MRI and CT at week 9. After completion of study, patients are followed up at weeks 2, 6, and 12.

Conditions

• Soft Tissue Sarcoma
• Stage I Soft Tissue Sarcoma of the Trunk and Extremities
• Stage II Soft Tissue Sarcoma of the Trunk and Extremities
• Stage III Soft Tissue Sarcoma of the Trunk and Extremities

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo CT
OTHER	Educational Intervention	Receive educational materials
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Physical Therapy	Receive prehabilitation physical therapy
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Telemedicine	Attend telemedicine visits

Timeline

• Start date: 2022-06-08
• Primary completion: 2026-06-08
• Completion: 2026-06-08
• First posted: 2022-09-02
• Last updated: 2026-01-16

Locations

1 site across 1 country: United States