RecruitingNot ApplicableNCT07609329

Preoperative Immunonutrition in Patients With Bone and Soft Tissue Sarcomas

Effect of Preoperative Immunomodulatory Nutritional Intervention on Postoperative Complications and Sarcopenia in Patients With Bone and Soft Tissue Sarcomas


Sponsor

St. Anne's University Hospital Brno, Czech Republic

Enrollment

100 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Forticare Advanced oral nutritional supplement for people with bone sarcoma, malnutrition, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTForticare Advanced oral nutritional supplement

Participants randomized to the intervention arm will receive preoperative oral immunomodulatory nutritional supplementation in addition to standard perioperative care. The supplement will be taken at home before the planned orthopedic tumor resection. The prescribed regimen will be Forticare Advanced oral nutritional supplement, 125 mL twice daily, for 14 days before surgery when clinically feasible. If the full 14-day period is not possible due to the clinical schedule, supplementation for at least 7 days will be accepted.


Locations(1)

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

Brno, Czechia

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NCT07609329


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