Bone SarcomaNCT07609329
Preoperative Immunonutrition in Patients With Bone and Soft Tissue Sarcomas
A study testing Forticare Advanced oral nutritional supplement in people with Bone Sarcoma and Soft Tissue Sarcoma, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Sarcoma, Soft Tissue Sarcoma, Sarcopenia
- What is being tested?
- Forticare Advanced oral nutritional supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
First Department of Orthopaedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia
Brno, 60200
Vasileios Apostolopoulos, 722101065, Vasilis.apo@email.cz
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Forticare Advanced oral nutritional supplement
- Keywords
- Sarcoma, Bone sarcoma, Soft tissue sarcoma, Malnutrition, Preoperative Nutrition, Immunonutrition, Sarcopenia
- Medical subject headings
- Bone Neoplasms, Sarcoma, Sarcopenia, Malnutrition, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forticare Advanced oral nutritional supplementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline assessment during diagnostic biopsy hospitalization.
Preoperative Functional Status
Functional status assessed using the Karnofsky Performance Status scale before planned orthopedic tumor resection.
Measured: Baseline
Length of Hospital Stay
Duration of hospitalization (days) from hospital admission for planned orthopedic tumor resection until hospital discharge.
Measured: 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.
Measured: Preoperative hospital admission (1 day prior surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Anne's University Hospital Brno, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michal Mahdal, M.D., Ph.D., Principal investigator, First Department of Orthopedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, CzechiaVasileios Apostolopoulos, M.D., Ph.D., Study director, First Department of Orthopedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, CzechiaBarbora Slanařová, Mgr., Principal investigator, Faculty of Medicine, Masaryk University, Brno, Czechia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609329
- Sponsor's protocol ID
- IIT/2026/58
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Immunomodulatory Nutritional Intervention on Postoperative Complications and Sarcopenia in Patients With Bone and Soft Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT07609329
- Acronym / sponsor ID
- IIT/2026/58
- Keywords
- Sarcoma, Bone sarcoma, Soft tissue sarcoma, Malnutrition, Preoperative Nutrition, Immunonutrition, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St. Anne's University Hospital Brno, Czech RepublicUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Forticare Advanced oral nutritional supplementParticipants 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forticare Advanced oral nutritional supplementParticipants 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. | Dietary supplement | Intervention Group |
Primary outcome
Clinically Relevant Postoperative Complications
Time frame: Within 30 days after surgery
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.
8 secondary outcomes
Change in skeletal muscle indices measured by CT-based body composition analysis at the L3 vertebral level
Time frame: Baseline (staging) and 6 months postoperatively (restaging).
Change in serum albumin concentration measured by standard clinical biochemistry testing
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
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
Time frame: From baseline assessment at diagnostic biopsy to hospital admission for planned surgery (1 day prior surgery).
Nutritional Risk Score
Time frame: At baseline assessment during diagnostic biopsy hospitalization.
Preoperative Functional Status
Time frame: Baseline
Length of Hospital Stay
Time frame: From hospital admission until hospital discharge, up to 30 days after surgery
Adherence to Preoperative Nutritional Supplementation
Time frame: Preoperative hospital admission (1 day prior surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michal Mahdal, M.D., Ph.D. principal investigator
First Department of Orthopedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia
Vasileios Apostolopoulos, M.D., Ph.D. study director
First Department of Orthopedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia
Barbora Slanařová, Mgr. principal investigator
Faculty of Medicine, Masaryk University, Brno, Czechia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forticare Advanced oral nutritional supplement in people with Bone Sarcoma and Soft Tissue Sarcoma, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vasileios Apostolopoulos, M.D., Ph.D. (722101065, vasileios.apostolopoulos@fnusa.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically Relevant Postoperative Complications (time frame: Within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.