Evaluating robotic rehabilitation and nutrition for patients with soft tissue sarcoma
Official title: Soft Tissue Sarcoma: Instrumented Evaluation of Motor Performance and Impact of Robotic Rehabilitation, Nutrition and Quality of Life Assessment (START-RUN1)
Run by Fondazione Policlinico Universitario Campus Bio-Medico · NCT06873685 · Data updated 2026-11-12
This study is testing if personalized robotic rehabilitation and nutrition support can help people with localized soft tissue sarcoma recover better after surgery and improve their quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Campus Bio-Medico Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 3 sites (Rome, Lazio and 2 other locations) |
| Status | Recruiting |
| Started | March 13, 2025 |
| Main results expected | December 31, 2025 |
| Study ends | August 31, 2026 |
| Registry record updated | March 21, 2025 |
| Trial ID | NCT06873685 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with primary localized soft tissue sarcoma eligible for limb-sparing surgery.
✕Probably not a fit
Patients with recurrent tumors, metastatic disease, or those requiring palliative surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on patients with localized soft tissue sarcoma who are undergoing surgical treatment. It aims to assess motor impairments and the effectiveness of personalized robotic rehabilitation techniques on motor recovery. Additionally, the study evaluates the impact of surgery and rehabilitation on patients' quality of life and nutritional status through various assessments and questionnaires. The primary endpoint is to measure functional deficits and motor quality before and after rehabilitation.
Why it matters
Potential benefit: If successful, this study could significantly improve motor recovery and quality of life for patients recovering from soft tissue sarcoma surgery.
How similar studies have gone: While the approach of using robotic rehabilitation is innovative, similar studies have shown promise in improving rehabilitation outcomes for surgical patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. patient with primary and localized STS who is a candidate for limb-sparing surgery or retroperitoneal multivisceral resection (including partial or complete resection of the iliopsoas muscle with functional loss and potential femoral nerve involvement) with curative intent; 2. age 18 years or older. Exclusion Criteria: 1. recurrent tumors; 2. metastatic disease; 3. candidate for palliative and non-radical surgery; 4. refusal to sign informed consent; 5. Pregnant or breastfeeding women at the time of screening.
Where it's running
-
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Lazio, Italy Recruiting -
Fondazione Don Carlo Gnocchi ONLUS
Roma, Rm, Italy Active not recruiting -
Istituto Nazionale Tumori-IRCCS-Fondazione G.Pascale
Naples, Italy Not yet recruiting
Study contacts
- Principal investigator: Bruno Vincenzi, MD, PhD — Fondazione Policlinico Universitario Campus Bio-Medico
- Study coordinator: Bruno Vincenzi
- Email: b.vincenzi@policlinicocampus.it
- Phone: +3906225411160
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.