NCT07609329 Preoperative Immunonutrition in Patients With Bone and Soft Tissue Sarcomas
| NCT ID | NCT07609329 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Anne's University Hospital Brno, Czech Republic |
| Condition | Bone Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-04-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate whether a short nutritional intervention before surgery can improve recovery in patients with bone and soft tissue sarcomas. Patients with these tumors often have a higher risk of poor nutrition and loss of muscle mass. These problems may increase the risk of complications after major orthopedic surgery. Participants will be randomly assigned to one of two groups. One group will receive a special oral nutritional supplement twice daily before surgery, in addition to standard care. The other group will receive standard care without the preoperative nutritional supplement. The main aim of the study is to compare the rate of clinically relevant postoperative complications within 30 days after surgery. The study will also evaluate changes in muscle mass on CT scans, blood markers of nutrition and inflammation, nutritional risk, functional status, length of hospital stay, and tolerance of the nutritional supplement.
Eligibility Criteria
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.
Contact & Investigator
Michal Mahdal, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
First Department of Orthopedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia
Frequently Asked Questions
Who can join the NCT07609329 clinical trial?
This trial is open to participants of all sexes, studying Bone Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07609329 currently recruiting?
Yes, NCT07609329 is actively recruiting participants. Contact the research team at vasileios.apostolopoulos@fnusa.cz for enrollment information.
Where is the NCT07609329 trial being conducted?
This trial is being conducted at Brno, Czechia.
Who is sponsoring the NCT07609329 clinical trial?
NCT07609329 is sponsored by St. Anne's University Hospital Brno, Czech Republic. The principal investigator is Michal Mahdal, M.D., Ph.D. at First Department of Orthopedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia. The trial plans to enroll 100 participants.