Personalized exercise program to improve recovery for soft tissue sarcoma patients
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
This study is testing whether a personalized exercise program can help patients with soft tissue sarcoma recover better during their treatment compared to those who only receive educational materials.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Scottsdale, Arizona) |
| Trial ID | NCT05526417 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a tailored prehabilitation exercise regimen for patients with deep soft tissue sarcomas undergoing radiotherapy and surgery. Participants are randomized into two groups: one group engages in personalized physical therapy exercises while receiving standard care, and the other group receives educational materials without the exercise component. The study aims to assess improvements in functional outcomes, quality of life, and adherence to the prehabilitation program. Various metrics, including the Toronto Extremity Salvage Score and quality of life questionnaires, will be used to measure the impact of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with localized deep soft tissue sarcoma of the lower extremity.
Not a fit: Patients with superficial soft tissue sarcomas or those with metastatic disease are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery and surgical outcomes for patients with soft tissue sarcoma.
How similar studies have performed: Other studies have shown promising results with prehabilitation approaches in surgical recovery, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Scottsdale, Arizona
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Krista A. Goulding, MD, MPH — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.