NCT00710632Unknown不适用
Predicting Weight Loss in People With Cancer: Development of a Screening Tool
Queen's Medical Center2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2007年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Percentage weight loss by measuring height and weight at baseline and at 3 months
研究概览
简要总结
RATIONALE: Screening tests may identify people with cancer who are at high risk of losing weight and help doctors plan better treatment.
PURPOSE: This clinical trial is studying how well a new screening tool works in predicting weight loss in patients with cancer.
详细描述
OBJECTIVES:
- To identify people with cancer who are at greatest risk of future weight loss by the development of a simple and practical screening tool.
- To estimate the reliability of the Appetite and Symptom Questionnaire (part 1).
- To develop a screening tool based on the ability of the optimal combination of items from the three measures (ASQ, MUST, CRP) to predict clinically significant weight loss over three months (part 2).
- To estimate the sensitivity and specificity at various cut-points of the developed screening tool in predicting clinically significant weight loss (> 10% weight loss or between 5% and 10% weight loss with a BMI < 20 kg/m^2) over three months (part 2).
OUTLINE: This is a two-part study.
- Part 1: Patients are asked to complete the Appetite and Symptom Questionnaire (ASQ) on two occasions, one week apart.
- Part 2: Patients are screened at baseline for risk of malnutrition using the Malnutrition Universal Screening Tool. Blood samples are also taken at this time to establish the level of C-reactive protein and patients complete the ASQ. Patients are weighed using calibrated scales and height measurements are obtained. Patients are asked about unplanned weight loss over the previous 3-6 months. Patients are weighed again at 3 months. Percentage weight loss is calculated at 3 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
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
- •DISEASE CHARACTERISTICS:
- •Meets 1 of the following criteria, depending on part of study:
- •Receiving radiotherapy for cancer at Nottingham City Hospital
- •Likely to be clinically stable over the duration of one week (i.e., not at high risk of disease or treatment-related appetite and weight loss)
- •Stable weight and appetite
- •Outpatient at Nottingham City Hospital with a confirmed diagnosis of primary lung or gastrointestinal cancer
- •Lost no more than 10% of pre-illness stable body weight
- •Lost no more than 5% of pre-illness stable body weight if body mass index (BMI) was less than 20 kg/m^2
- •BMI ≥ 18.5 kg/m^2
- •PATIENT CHARACTERISTICS:
- •No condition impairing the ability to swallow
- •Not receiving enteral tube feeding or parenteral nutrition (part 2)
- •Able to be weighed (part 2)
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No concurrent radiotherapy to the head, neck or upper gastrointestinal tract area
排除标准
- 未提供
结局指标
主要结局
Percentage weight loss by measuring height and weight at baseline and at 3 months
Malnutrition Universal Screening Tool Score at initial screening
Response to the Appetite and Symptom Questionnaire at baseline
Level of blood C-reactive protein at baseline
Clinical condition, defined as diagnosis and stage of disease, treatment, and performance status at baseline
次要结局
未报告次要终点
研究者
研究点 (2)
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