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临床试验/NCT06997302
NCT06997302进行中(未招募)不适用

A Study on the Impact of Intelligent Nutrition Management on Clinical Outcomes in Chemotherapy Patients With Gastrointestinal Malignancies

Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
150
试验地点
1
主要终点
European Nutritional Risk Screening (NRS) 2002 scores

研究概览

简要总结

An increasing body of evidence suggests that nutritional status is a key factor in determining the quality of life of cancer patients. The sensitivity of cancer patients to anti-tumor treatments, the occurrence of side effects, and their quality of life are closely related to their nutritional status. Data show that about 50% of cancer patients experience a weight loss of more than 10% at the time of diagnosis and treatment, and once patients enter a cachexia state, the weight loss becomes difficult to reverse. Therefore, the extent to which nutritional interventions can impact clinical outcomes in these patients needs to be answered through clinical research. Currently, there are few studies using randomized controlled trials (RCTs) to explore how nutritional interventions can improve patients' quality of life, particularly in terms of prolonging survival. A recent RCT in a smaller sample population found that long-term, intensive, individualized nutritional counseling and support not only improved malnutrition in cancer patients, reduced treatment complications, and enhanced quality of life but also significantly extended survival time.

This study is a prospective, randomized controlled clinical trial aimed at investigating the effect of full-scale intelligent nutrition management in gastrointestinal malignancy patients (esophageal cancer, gastric cancer) undergoing chemotherapy. The study attempts to confirm that full-scale intelligent nutrition management can benefit these patients by maintaining or improving their nutritional status, and that the clinical effectiveness of intelligent nutrition management is comparable to that of professional nutritionists. This research will also provide clinical evidence for the intelligent and standardized nutritional treatment of cancer patients during the chemotherapy period.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age ≥ 18 years;
  • •Voluntarily agree to participate and sign the informed consent form;
  • •Diagnosed with gastrointestinal malignancy (esophageal cancer, gastric cancer) and planned to undergo chemotherapy;
  • •Physical activity is acceptable, and capable of undergoing body composition analysis.

排除标准

  • •Uncontrolled or severe heart, liver, lung, and kidney diseases;
  • •History of stroke, epilepsy, or primary brain cancer, or patients with brain metastases from cancer;
  • •Pregnant individuals;
  • •Individuals allergic to milk, whey protein, etc.

研究组 & 干预措施

Control group.

No Intervention

In the Control group, necessary nutritional support or dietary guidance were provided by clinical physicians following standard clinical procedures.

Study group 1

Experimental

In Research Group 1, nutritional status was assessed using a clinical nutrition analyzer, with interventions tailored to the system-generated "Nutritional Diagnosis Report" and recommendations.

干预措施: Nutritional Supplement (Other)

Study group 2

Experimental

Patients in Research Group 2 underwent evaluation by a multidisciplinary team comprising clinical physicians and dietitians, who collaboratively designed and delivered nutritional support.

干预措施: Nutritional Supplement (Other)

结局指标

主要结局

European Nutritional Risk Screening (NRS) 2002 scores

时间窗: 9 weeks

NRS2002 scores for participants in all groups after 9-week nutritional intervention.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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