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临床试验/NCT00710632
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

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

发起方
Queen's Medical Center
申办方类型
Other

研究点 (2)

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