July 22, 2025
Orthopedic experts in soft tissue sarcoma (STS) at Mayo Clinic in Arizona are leading a clinical trial studying prehabilitation for patients with this malignancy whose physicians have scheduled radiotherapy and surgical resection. The study is active and enrolling patients, and healthcare professionals may refer patients for an assessment.
Study design
This study is a single-blind, randomized feasibility trial. The principal investigator, Krista A. Goulding, M.D., M.P.H., is an orthopedic surgeon specializing in musculoskeletal oncology and adult reconstruction at Mayo Clinic in Arizona. In this study, Dr. Goulding and fellow investigators are assessing the feasibility of presurgical, customized prehabilitation during radiotherapy to optimize recovery and quality of life for patients with lower extremity STS.
The hypothesis Dr. Goulding and colleagues are testing is that participants in the personalized prehabilitation program will recover physical function capacity to a level higher than expected, while participants in the informational support group will recover function as expected based on current care estimates.
The study involves two arms in which patients will participate over a 22-week period:
- For the intervention group, physicians in orthopedic oncology and radiation oncology and a physical therapist (PT) specializing in cancer rehabilitation develop an individualized rehabilitation plan for each participant. One factor in customization is tumor location. Each participant will have weekly in-person meetings for prehabilitation during neoadjuvant radiotherapy. Following the prehabilitation, participants will have a five-week rest period, during which they will participate in weekly virtual PT meetings. Patients will use wearable technology for monitoring before and after surgery and will undergo a gait quality assessment.
- The control group will follow an Enhanced Recovery After Surgery protocol, including equal attention as the intervention group participants and informational support. These participants will be involved in weekly reviews of an information pamphlet over the five-week neoadjuvant radiotherapy. After radiotherapy, participants have a four-week rest period before surgery and will participate in a weekly virtual material review.
The primary aims of this study include:
- Evaluation of which approach most effectively improves the patients' functional outcomes, as measured by an observed Toronto Extremity Salvage Score (TESS).
- Assessment of which measures and metrics are most responsive to the intervention, using the TESS, six-minute walk test, wearable monitoring technology and daily step count.
- Estimation of acceptability, adherence, recruitment and retention rates for study participants.
The study's secondary aim is to compare quality of life changes resulting from the prehabilitation intervention over time, measured by the Edmonton Symptom Assessment Scale, the Patient Generated Index and the EQ-5D-5L health-related quality of life assessment.
Eligibility
To be eligible for this study, participants must meet these criteria:
- Adults, 18 and older.
- All gender types.
- Histologically or cytologically proven deep STS of the lower extremity.
- Localized in the lower extremity.
All participants must be able to provide appropriate consent or have an appropriate representative available to do so.
Patients diagnosed with STS who are ineligible for this study are those with:
- Both upper and lower extremity involvement.
- Metastatic disease (distant or nodal).
- STSs that are in a superficial location relative to fascia.
How to enroll a patient or get more information
To enroll a patient or discuss the study, contact the Mayo Clinic Cancer Center Clinical Trials Referral Office at 855-776-0015.
STS background
STS is a rare disease that represents approximately 1% of all cancers. Dr. Goulding notes that most primary healthcare professionals will only see a patient with sarcoma a few times over the course of their careers. Patients with this disease often see many physicians prior to referral to Orthopedic Oncology for evaluation and treatment of STS.
The mean age for STS is 50 to 60, but patients' ages range from childhood to older adults. Patients' fitness status varies, and Dr. Goulding has seen patients with this disease as varied as:
- A 25-year-old who skis, works and goes to school.
- A 77-year-old who regularly plays pickleball.
- A 70-year-old who is physically inactive.
This disease varies significantly in presentation and behavior. Patients with STS usually present with a painless, growing lump; occasionally, patients have pain if the mass is growing rapidly, compressing a nerve or rarely, invading into bone.
According to Dr. Goulding, the journey for patients with an STS diagnosis is emotional. She indicates that patients who see her often feel anxious about the growing lump. She also notes that this diagnosis typically comes as a complete surprise for patients.
"A diagnosis of sarcoma is a shock for many patients — a moment in time in these patients' lives when they have difficulty imagining their future. This can be a very difficult time for patients and their families," says Dr. Goulding.
Current outlook for patients with STS and study impetus
Decades ago, the outlook for patients with STS was bleak, according to Dr. Goulding.
"Years ago, many patients with STS had radical resections or amputations," says Dr. Goulding. "Now, we can save 95% of affected limbs. We can deliver personalized treatments including radiation, surgery and chemotherapy on a case-by-case basis with the goal of improving survival, function and quality of life."
Although STS treatment today has changed significantly compared with past practices, healthcare professionals who wish to optimize this cancer treatment and its recovery face additional challenges.
"Up to 50% of patients with STS report physical dysfunction, and many are unable to return to work or to their prior level of work after completing their treatment," says Dr. Goulding. "This leads to radical changes in patients' role functioning."
Over the course of her academic training, Dr. Goulding developed an interest in this patient population and the opportunity to offer an enhanced recovery program with functional optimization following STS resection. Beyond curing patients' cancers, Dr. Goulding sees the present challenge as working to change a landscape where patients with STS are at risk of major functional deficits after completing their treatment plans.
"We want to get patients with STS back to the highest level of function and quality of life possible, back to doing activities they enjoy, and returning to work," says Dr. Goulding.
For more information
Clinical trials: Individualized prehabilitation for enhancing recovery and surgical outcomes in patients undergoing radiotherapy and surgery for soft tissue sarcoma. Mayo Clinic.
Refer a patient to Mayo Clinic.