Effect of Preoperative Immunomodulatory Nutritional Intervention on Postoperative Complications and Sarcopenia in Patients With Bone and Soft Tissue Sarcomas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
