Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Sarcoma | Bone Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Malnutrition | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
| Sarcopenia | — | UNRESOLVED | — |
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Forticare Advanced oral nutritional supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- Participants in this arm will receive standard perioperative care plus preoperative oral immunomodulatory nutritional support. The nutritional supplement will be taken at home before the planned orthopedic tumor resection. Adherence to the supplement and tolerance of the intervention will be assessed at hospital admission for surgery.
- interventionNames
- Dietary Supplement: Forticare Advanced oral nutritional supplement
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Participants in this arm will receive standard perioperative care without additional preoperative oral immunomodulatory nutritional supplementation. This arm reflects routine clinical practice and will serve as the control group for comparison with the intervention arm.
Primary outcomes (1)
- measure
- Clinically Relevant Postoperative Complications
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available