Health Trials

About this trial

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

Qualifiers

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.

Disqualifiers

Indication for urgent surgery.

Disseminated disease with more than five metastases.

Ongoing parenteral nutrition before study enrollment.

Inability to receive oral intake.

Trial design

Treatments tested in this trial

  • Forticare Advanced oral nutritional supplement

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

1
First Department of Orthopaedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia60200, Brno Czechia

Sponsors and collaborators

St. Anne's University Hospital Brno, Czech Republic

Lead sponsor

Source ClinicalTrials.gov