Clinical trial NCT05526417: Individualized Prehabilitation for Enhancing Recovery and Surgical Outcomes in Patients Undergoing Radiotherapy and Surgery for Soft Tissue Sarcoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically-proven deep soft tissue sarcoma (STS) of the lower extremity
* Localized
* Adults, 18 and older
* All gender types
* Subjects must be able to provide appropriate consent or have an appropriate representative available to do so

Exclusion Criteria:

* Soft tissue sarcomas that are in a superficial location relative to fascia
* Patients with metastatic disease (distant or nodal)
* Both and upper and lower extremity involvement

Primary outcomes:
measure: Feasibility as measured by recruitment, retention, adherence, and acceptability
timeFrame: Up to 22 weeks
measure: Efficacy potential
timeFrame: Up to 22 weeks
measure: Toronto Extremity Salvage Score
timeFrame: At 2, 6, and 12 weeks
measure: Functional walking capacity
timeFrame: At 2, 6, and 12 weeks
measure: Gait quality
timeFrame: Up to 22 weeks
measure: Daily step count
timeFrame: Up to 22 weeks
Secondary outcomes:
measure: Symptom status
timeFrame: Up to 22 weeks
measure: Global health related quality of life
timeFrame: Up to 22 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Krista A. Goulding, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: