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Prehabilitation for Soft Tissue Sarcoma

N/A

Recruiting

Led By Krista A. Goulding, MD, MPH

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2, 6, and 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether patients who receive a tailored prehabilitation exercise regimen during radiotherapy have better surgical outcomes than those who do not.

Who is the study for?

This trial is for adults over 18 with a confirmed diagnosis of deep soft tissue sarcoma in the lower extremity, who can consent to participate. It's not for those with metastatic disease, tumors in superficial locations relative to fascia, or involvement of both upper and lower limbs.

What is being tested?

The study tests if a personalized exercise program (prehabilitation) during radiotherapy before surgery improves recovery and surgical outcomes for patients with soft tissue sarcomas compared to standard care without prehabilitation.

What are the potential side effects?

While this trial focuses on exercise and education rather than drugs, potential side effects may include typical risks associated with physical therapy such as muscle soreness or strain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2, 6, and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2, 6, and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2, 6, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Daily step count

Efficacy potential

Feasibility as measured by recruitment, retention, adherence, and acceptability

+3 more

Secondary study objectives

Global health related quality of life

Symptom status

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (prehabilitation physical therapy)Experimental Treatment6 Interventions

Patients perform personalized prehabilitation physical therapy exercises 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 MRI and CT at week 9.

Group II: Arm II (educational materials)Active Control5 Interventions

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 and prior to standard of care surgery. Patients undergo MRI and CT at week 9.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180