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
St. Anne's University Hospital Brno, Czech Republic
100 participants
Apr 1, 2026
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
Inclusion Criteria8
- 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 Criteria7
- 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.
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Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT07609329