NUT Project: Nutritional Support in Thoracic Oncology
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
- 主要终点
- Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of height (cm)
研究概览
简要总结
monitoring of the patient's nutritional status from diagnosis ensuring a dietetic-nutritional intervention throughout the treatment process
详细描述
During the first visit, a nutritional screening test such as the Nutritional Risk Screening 2002 (NRS-2002) will be performed, which represents one of the main internationally validated screening tools (recommended by ESPEN and SINPE) for the risk of malnutrition. The test considers both the nutritional status and the degree of severity of the underlying pathology.
The final score (Total Score) is the sum of three parameters:
- Nutritional Status: Assessed by percentage of weight loss, decline in dietary income, and BMI. (Score from 0 to 3).
- Severity of the Pathology: Evaluated according to the increased metabolic requirement linked to the disease (e.g. surgery, COPD, tumors, intensive care). (Score from 0 to 3).
- Age: For patients >70 years of age, a point is added.
Based on the final score:
- patients with a score < 3 (low nutritional risk) will receive simple nutritional advice from the oncologist on the correct management of their diet during treatment.
- patients with score ≥ 3 (high nutritional risk) will be enrolled, after signing the informed consent, and subjected to a dietary - nutritional assessment as per clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Men and women aged ≥ 18 years,
- •Diagnosis of advanced/metastatic non-small cell and small cell lung cancer candidates for first-line treatment of thoracic cancer
- •High nutritional risk according to NRS2002 screening test (score ≥3)
- •Nutritional assessment and care at the center
- •Sign Informed Consent
排除标准
- •Lack of availability of information regarding anamnestic data,
- •Failure to sign informed consent
结局指标
主要结局
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of height (cm)
时间窗: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of weight (kg)
时间窗: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of BMI (kg/m^2)
时间窗: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of fatigue (Units on a Scale)
时间窗: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of adverse events
时间窗: through study completion, an average of 1 year
Describe the impact of dietary intervention and/or nutritional support on the nutritional status of patients during antiblastic treatments in terms of strength (Hand Grip)
时间窗: through study completion, an average of 1 year
次要结局
未报告次要终点