此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Preoperative Immunonutrition in Patients With Bone and Soft Tissue Sarcomas

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.

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Brno、捷克语、60200
        • 招聘中
        • First Department of Orthopaedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
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.
无干预: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Clinically Relevant Postoperative Complications
大体时间: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.
Within 30 days after surgery

次要结果测量

结果测量
措施说明
大体时间
Change in skeletal muscle indices measured by CT-based body composition analysis at the L3 vertebral level
大体时间:Baseline (staging) and 6 months postoperatively (restaging).
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.
Baseline (staging) and 6 months postoperatively (restaging).
Change in serum albumin concentration measured by standard clinical biochemistry testing
大体时间:From baseline assessment at diagnostic biopsy to hospital admission for planned surgery (1 day prior surgery).
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.
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
大体时间:From baseline assessment at diagnostic biopsy to hospital admission for planned surgery (1 day prior surgery).
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.
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
大体时间:From baseline assessment at diagnostic biopsy to hospital admission for planned surgery (1 day prior surgery).
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.
From baseline assessment at diagnostic biopsy to hospital admission for planned surgery (1 day prior surgery).
Nutritional Risk Score
大体时间:At baseline assessment during diagnostic biopsy hospitalization.
Nutritional risk assessed using the Nutritional Risk Screening 2002 tool.
At baseline assessment during diagnostic biopsy hospitalization.
Preoperative Functional Status
大体时间:Baseline
Functional status assessed using the Karnofsky Performance Status scale before planned orthopedic tumor resection.
Baseline
Length of Hospital Stay
大体时间:From hospital admission until hospital discharge, up to 30 days after surgery
Duration of hospitalization (days) from hospital admission for planned orthopedic tumor resection until hospital discharge.
From hospital admission until hospital discharge, up to 30 days after surgery
Adherence to Preoperative Nutritional Supplementation
大体时间:Preoperative hospital admission (1 day prior surgery)
Adherence to the prescribed preoperative oral nutritional supplement regimen assessed at preoperative hospital admission.
Preoperative hospital admission (1 day prior surgery)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Michal Mahdal, M.D., Ph.D.、First Department of Orthopedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia
  • 研究主任:Vasileios Apostolopoulos, M.D., Ph.D.、First Department of Orthopedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia
  • 首席研究员:Barbora Slanařová, Mgr.、Faculty of Medicine, Masaryk University, Brno, Czechia

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月1日

初级完成 (估计的)

2027年12月31日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年5月13日

首先提交符合 QC 标准的

2026年5月19日

首次发布 (实际的)

2026年5月27日

研究记录更新

最后更新发布 (实际的)

2026年5月27日

上次提交的符合 QC 标准的更新

2026年5月19日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅