Preoperative Immunonutrition in Patients With Bone and Soft Tissue Sarcomas
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSt. Anne's University Hospital Brno, Czech Republic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Indication for urgent surgery.
Disseminated disease with more than five metastases.
Ongoing parenteral nutrition before study enrollment.
Inability to receive oral intake.
Trial design
Design model
Parallel
Treatments tested in this trial
Forticare Advanced oral nutritional supplement
Dietary 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Within 30 days after surgerySecondary outcomes
1
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).2
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).3
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).4
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov