Preoperative Immunonutrition in Patients With Bone and Soft Tissue Sarcomas

NCT07609329 | Recruiting

• 1 other identifier: IIT/2026/58
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bone Sarcoma; Soft Tissue Sarcoma; Sarcopenia; Malnutrition; Postoperative Complications

Keywords

Sarcoma; Bone sarcoma; Soft tissue sarcoma; Malnutrition; Preoperative Nutrition; Immunonutrition; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in skeletal muscle indices measured by CT-based body composition analysis at the L3 vertebral level

  Baseline (staging) and 6 months postoperatively (restaging).

• Change in serum albumin concentration measured by standard clinical biochemistry testing

  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

  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

  From baseline assessment at diagnostic biopsy to hospital admission for planned surgery (1 day prior surgery).

• Nutritional Risk Score

  At baseline assessment during diagnostic biopsy hospitalization.

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Forticare Advanced oral nutritional supplement DIETARY_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.

Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Anne's University Hospital Brno, Czech Republic: lead

Study Sites (1)

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

Brno, 60200, Czechia

RECRUITING

MeSH Terms

Conditions

Bone Neoplasms; Sarcoma; Sarcopenia; Malnutrition; Postoperative Complications

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes

Study Officials

• Michal Mahdal, M.D., Ph.D.

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

  PRINCIPAL INVESTIGATOR

• Vasileios Apostolopoulos, M.D., Ph.D.

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

  STUDY DIRECTOR

• Barbora Slanařová, Mgr.

  Faculty of Medicine, Masaryk University, Brno, Czechia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vasileios Apostolopoulos, M.D., Ph.D.

CONTACT

722101065; vasileios.apostolopoulos@fnusa.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel-group randomized controlled study comparing standard care with standard care plus preoperative oral immunomodulatory nutritional support in patients undergoing planned orthopedic resection for bone or soft tissue sarcoma.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

CZ (1)