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

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.

Study Overview

• Status: Recruiting
• Conditions: Soft Tissue Sarcoma; Postoperative Complications; Malnutrition; Sarcopenia; Bone Sarcoma
• Intervention / Treatment: Dietary supplement: Forticare Advanced oral nutritional supplement

Detailed Description

Patients with bone and soft tissue sarcomas often require planned major orthopedic surgery as part of their treatment. These operations may include wide tumor resection and, in some cases, complex reconstruction of the affected limb or anatomical region. Because of the extent of surgery and the underlying oncologic disease, these patients may be at increased risk of postoperative complications, impaired wound healing, longer hospitalization, and slower functional recovery.

Nutritional status is an important factor that may influence surgical outcomes. Patients with sarcoma may develop malnutrition or reduced skeletal muscle mass due to the tumor itself, cancer-related systemic inflammation, decreased physical activity, reduced food intake, or previous oncologic treatment. Sarcopenia and poor nutritional reserve may decrease the patient's ability to tolerate major surgery and may contribute to a higher risk of postoperative morbidity.

Preoperative nutritional optimization is recommended in several areas of oncologic surgery, but evidence specifically focused on patients with bone and soft tissue sarcomas remains limited. In this population, there is no clear consensus regarding the optimal nutritional strategy, timing, or expected clinical benefit of short-term preoperative nutritional support. This creates a need for prospective data in real-world sarcoma care.

This prospective, randomized, controlled study will evaluate whether a standardized preoperative immunomodulatory nutritional intervention can improve postoperative outcomes in adult patients with histologically confirmed bone or soft tissue sarcoma who are scheduled for elective orthopedic tumor resection.

Eligible participants will be randomized to one of two study groups. Patients in the intervention group will receive standard care together with preoperative oral immunomodulatory nutritional support before the planned surgery. Patients in the control group will receive standard care without additional preoperative nutritional supplementation. The intervention will be carried out in the home setting during the preoperative period, reflecting routine clinical practice.

Patients will undergo nutritional assessment by a clinical nutrition therapist during the diagnostic and preoperative treatment pathway. If sarcoma is confirmed and the patient is indicated for planned orthopedic resection, the nutritional intervention will be prescribed for home use in the intervention group. At admission for surgery, adherence to the supplement and tolerance of the nutritional intervention will be assessed.

The primary objective of the study is to determine whether preoperative immunomodulatory nutrition reduces the occurrence of clinically relevant postoperative complications within 30 days after orthopedic resection. Complications will be evaluated using a standardized classification system and assessed through blinded review of medical records.

Secondary objectives will assess several aspects of perioperative recovery and nutritional status. These include changes in skeletal muscle mass using CT-based body composition analysis, laboratory markers related to nutrition and systemic inflammation, baseline nutritional risk, preoperative functional status, length of hospital stay, and the feasibility of the intervention based on adherence and tolerance.

The study will use CT scans performed as part of standard oncologic staging and restaging to evaluate changes in muscle mass. This approach allows assessment of sarcopenia without adding imaging procedures beyond routine clinical care. Laboratory parameters and clinical assessments will also be collected within the standard perioperative pathway whenever possible.

The study is designed to reflect real-world treatment conditions in a tertiary sarcoma center. The results may help clarify whether short-term preoperative immunonutrition is feasible and clinically useful in patients with bone and soft tissue sarcomas undergoing major orthopedic surgery. The findings may also support future development of perioperative nutritional protocols for this high-risk patient population.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vasileios Apostolopoulos, M.D., Ph.D.; Phone Number: 722101065; Email: vasileios.apostolopoulos@fnusa.cz

Study Locations

• Czechia
  • Brno, Czechia, 60200
    • Recruiting
    • First Department of Orthopaedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia
    • Contact: Vasileios Apostolopoulos; Phone Number: 722101065; Email: Vasilis.apo@email.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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.	Dietary supplement: Forticare 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.
No Intervention: Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically Relevant Postoperative Complications	Occurrence of clinically relevant postoperative complications, defined as grade II or higher according to the Clavien-Dindo classification, within 30 days after planned orthopedic tumor resection.	Within 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in skeletal muscle indices measured by CT-based body composition analysis at the L3 vertebral level	Changes in skeletal muscle parameters measured on CT imaging at the L3 vertebral level, including Skeletal Muscle Index (SMI), Paraspinal Muscle Index (PSMI), and Psoas Muscle Index (PMI). SMI represents the cross-sectional area of all skeletal muscles at L3 normalized to patient height (cm²/m²). PSMI represents the normalized cross-sectional area of paraspinal muscles at L3. PMI represents the normalized cross-sectional area of the psoas muscle at L3. Measurements will be assessed on baseline and follow-up CT examinations using CT-based body composition analysis.	Baseline (staging) and 6 months postoperatively (restaging).
Change in serum albumin concentration measured by standard clinical biochemistry testing	Change in serum albumin concentration (g/L), measured using standard clinical biochemistry laboratory testing, between baseline assessment at diagnostic biopsy and preoperative hospital admission for planned surgery.	From baseline assessment at diagnostic biopsy to hospital admission for planned surgery (1 day prior surgery).
Change in serum prealbumin concentration measured by standard clinical biochemistry testing	Change in serum prealbumin concentration (mg/dL), measured using standard clinical biochemistry laboratory testing, between baseline assessment at diagnostic biopsy and preoperative hospital admission for planned surgery.	From baseline assessment at diagnostic biopsy to hospital admission for planned surgery (1 day prior surgery).
Change in serum C-reactive protein concentration measured by standard clinical biochemistry testing	Change in serum C-reactive protein concentration (mg/L), measured using standard clinical biochemistry laboratory testing, between baseline assessment at diagnostic biopsy and preoperative hospital admission for planned surgery.	From baseline assessment at diagnostic biopsy to hospital admission for planned surgery (1 day prior surgery).
Nutritional Risk Score	Nutritional risk assessed using the Nutritional Risk Screening 2002 tool.	At baseline assessment during diagnostic biopsy hospitalization.
Preoperative Functional Status	Functional status assessed using the Karnofsky Performance Status scale before planned orthopedic tumor resection.	Baseline
Length of Hospital Stay	Duration of hospitalization (days) from hospital admission for planned orthopedic tumor resection until hospital discharge.	From hospital admission until hospital discharge, up to 30 days after surgery
Adherence to Preoperative Nutritional Supplementation	Adherence to the prescribed preoperative oral nutritional supplement regimen assessed at preoperative hospital admission.	Preoperative hospital admission (1 day prior surgery)

Collaborators and Investigators

• Sponsor: St. Anne's University Hospital Brno, Czech Republic
• Investigators: Principal Investigator: Michal Mahdal, M.D., Ph.D., First Department of Orthopedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia; Study Director: Vasileios Apostolopoulos, M.D., Ph.D., First Department of Orthopedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia; Principal Investigator: Barbora Slanařová, Mgr., Faculty of Medicine, Masaryk University, Brno, Czechia

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Sarcopenia; Sarcoma; Malnutrition; Immunonutrition; Soft tissue sarcoma; Bone sarcoma; Preoperative Nutrition
• Additional Relevant MeSH Terms: Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Nutrition Disorders; Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Malnutrition; Sarcoma; Sarcopenia; Postoperative Complications; Bone Neoplasms
• Other Study ID Numbers: IIT/2026/58

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No