Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
| Stage III Soft Tissue Sarcoma of the Trunk and Extremities | Soft Tissue Sarcoma of the Trunk and Extremities | CURATED_BROADER | 0.78 |
| Stage II Soft Tissue Sarcoma of the Trunk and Extremities | Soft Tissue Sarcoma of the Trunk and Extremities | CURATED_BROADER | 0.78 |
| Stage I Soft Tissue Sarcoma of the Trunk and Extremities | Soft Tissue Sarcoma of the Trunk and Extremities | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Educational Intervention | Other | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Physical Therapy | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Telemedicine | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (prehabilitation physical therapy)
- description
- 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.
- interventionNames
- Procedure: Computed Tomography
- Other: Educational Intervention
- Procedure: Magnetic Resonance Imaging
- Procedure: Physical Therapy
- Other: Questionnaire Administration
- Other: Telemedicine
- type
- ACTIVE_COMPARATOR
- label
- Arm II (educational materials)
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available