Muscle Atrophy Clinical Trials

Find Muscle Atrophy Clinical Trials Near You

Effect of Preoperative Immunomodulatory Nutritional Intervention on Postoperative Complications and Sarcopenia in Patients With Bone and Soft Tissue Sarcomas

Status: Recruiting
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Contact Information
Primary
Vasileios Apostolopoulos, M.D., Ph.D.
vasileios.apostolopoulos@fnusa.cz
722101065
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Intervention Group
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.
No_intervention: Control Group
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.
Sponsors
Leads: St. Anne's University Hospital Brno, Czech Republic

This content was sourced from clinicaltrials.gov