An interventional study of Forticare Advanced oral nutritional supplement in Bone Sarcoma, Soft Tissue Sarcoma and Sarcopenia, sponsored by St. Anne's University Hospital Brno, Czech Republic. Recruiting at 1 site in Czechia. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by St. Anne's University Hospital Brno, Czech Republic · Not applicable, Interventional, and Supportive care
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.
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.
258 studies on the registry are indexed under Bone Neoplasms; 68 are open to participants now.
This study's planned enrollment of 100 is above the median of 44 across 163 interventional studies indexed under Bone Neoplasms.
Browse Bone Neoplasms studies →St. Anne's University Hospital Brno, Czech Republic is the lead sponsor of 25 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
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.
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.
Time frame: Within 30 days after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline assessment during diagnostic biopsy hospitalization.
Preoperative Functional Status
Functional status assessed using the Karnofsky Performance Status scale before planned orthopedic tumor resection.
Time frame: Baseline
Length of Hospital Stay
Duration of hospitalization (days) from hospital admission for planned orthopedic tumor resection until hospital discharge.
Time frame: 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.
Time frame: Preoperative hospital admission (1 day prior surgery)
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Dec 2027, 20 months after the start.
Of 34 non-industry interventional studies with no phase under Bone Neoplasms, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 70. This study's planned 20 months is below that.
Counting every sponsor, half of 40 studies reached it within 50 months; a quarter within 14 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
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St. Anne's University Hospital Brno, Czech Republic