Evaluating robotic rehabilitation and nutrition for patients with soft tissue sarcoma
Soft Tissue Sarcoma: Instrumented Evaluation of Motor Performance and Impact of Robotic Rehabilitation, Nutrition and Quality of Life Assessment (START-RUN1)
NA · Fondazione Policlinico Universitario Campus Bio-Medico · NCT06873685
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Campus Bio-Medico (other) |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 3 sites (Rome, Lazio and 2 other locations) |
| Trial ID | NCT06873685 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with primary localized soft tissue sarcoma eligible for limb-sparing surgery.
Not a fit: Patients with recurrent tumors, metastatic disease, or those requiring palliative surgery may not benefit from this study.
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 performed: While the approach of using robotic rehabilitation is innovative, similar studies have shown promise in improving rehabilitation outcomes for surgical patients.
Eligibility criteria
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 this trial is running
Rome, Lazio and 2 other locations
- 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
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.
Conditions: Sarcoma, Soft Tissue, rehabilitation, nutrition, quality of life, instrumented assessment of motor performance