Preoperative Immunonutrition for bone and soft tissue sarcoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, randomized trial examines whether adding a standardized oral immunonutrition supplement before planned orthopedic tumor surgery reduces postoperative complications within 30 days. Participants with bone or soft tissue sarcomas and adequate oral intake are assigned to either the preoperative supplement plus standard care or standard care alone. Outcomes include 30-day complication rates, CT-based muscle mass changes, nutritional and inflammatory blood markers, nutritional risk, functional status, length of stay, and tolerability of the supplement. The study targets adults with localized or oligometastatic disease who are scheduled for resection and can receive the supplement for at least 7 days (preferably 14). This is a pragmatic, real-world assessment of whether short-term preoperative nutrition can improve recovery in sarcoma patients undergoing major orthopedic surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants must meet all of the following criteria:
* Adult patients aged 18 years or older.
* Histologically confirmed bone sarcoma or soft tissue sarcoma.
* Localized or oligometastatic disease.
* Indicated for planned orthopedic tumor resection.
* Preoperative interval allowing administration of the nutritional intervention for at least 7 days, with 14 days preferred when clinically feasible.
* Ability to receive oral nutritional supplementation.
* Signed informed consent for participation in the study.

Exclusion Criteria:

* Participants will be excluded if any of the following criteria are present:
* Indication for urgent surgery.
* Disseminated disease with more than five metastases.
* Ongoing parenteral nutrition before study enrollment.
* Inability to receive oral intake.
* Severe hepatic failure.
* Severe renal failure.

Where it's running

• First Department of Orthopaedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia
  Brno, Czechia Recruiting

Study contacts

• Principal investigator: Michal Mahdal, M.D., Ph.D. — First Department of Orthopedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia
• Study coordinator: Vasileios Apostolopoulos, M.D., Ph.D.
• Email: vasileios.apostolopoulos@fnusa.cz
• Phone: 722101065

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.