Preoperative Immunonutrition in Patients With Bone and Soft Tissue Sarcomas (NCT07609329) | Clinical Trial Compass
RecruitingNot Applicable
Preoperative Immunonutrition in Patients With Bone and Soft Tissue Sarcomas
Czechia100 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinically Relevant Postoperative Complications
Timeframe: Within 30 days after surgery
Trial details
NCT IDNCT07609329
SponsorSt. Anne's University Hospital Brno, Czech Republic