RecruitingNot ApplicableNCT05526417

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


Sponsor

Mayo Clinic

Enrollment

30 participants

Start Date

Jun 8, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria3

  • 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

Interventions

PROCEDUREComputed Tomography

Undergo CT

OTHEREducational Intervention

Receive educational materials

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPhysical Therapy

Receive prehabilitation physical therapy

OTHERQuestionnaire Administration

Ancillary studies

OTHERTelemedicine

Attend telemedicine visits


Locations(1)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

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NCT05526417


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