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临床试验/NCT07167082
NCT07167082已完成不适用

Integrated Assessment of Cachexia, Body Composition, and Patient-Reported Outcomes in Unplanned Hospitalizations of Metastatic Cancer Patients: The PRO-HAND Study

Ankara Etlik City Hospital1 个研究点 分布在 1 个国家目标入组 233 人开始时间: 2024年9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
已完成
发起方
入组人数
233
试验地点
1
主要终点
30-day All-Cause Mortality

研究概览

简要总结

This prospective observational cohort study aims to evaluate whether integrated bedside assessment of handgrip strength, cachexia-related indices, body composition, and patient-reported outcomes improves short-term prognostic stratification in hospitalized patients with metastatic cancer. Handgrip strength is a simple, rapid, and non-invasive measure of muscle function and physical reserve, and it is increasingly recognized as an indicator of frailty, sarcopenia, nutritional status, and cancer cachexia. In addition to handgrip strength, this study evaluates the prognostic value of the handgrip strength-cachexia index, bioelectrical impedance analysis-derived body composition parameters, the CRP-triglyceride-glucose index, and validated patient-reported outcome measures. The study will examine whether these admission-time assessments are associated with 30-day all-cause mortality, 90-day all-cause mortality, and 30-day unplanned hospital readmission.

详细描述

Handgrip strength declines with age and is associated with frailty, sarcopenia, cancer cachexia, nutritional deterioration, and adverse clinical outcomes in patients with cancer. In this prospective observational cohort study, consecutive adult patients with histologically or cytologically confirmed metastatic solid malignancies undergoing unplanned hospitalization will be assessed at the time of admission. Handgrip strength will be measured within the first 48 hours of admission using a calibrated hydraulic hand dynamometer. Measurements will be performed on the dominant hand, with patients seated, the elbow flexed at 90 degrees, and the wrist in a neutral position, according to standardized procedures. Three consecutive measurements will be obtained, and the highest value will be recorded for analysis.

In addition to handgrip strength, admission-time assessments will include routine laboratory parameters, the handgrip strength-cachexia index, the CRP-triglyceride-glucose index, bioelectrical impedance analysis-derived body composition measures, and validated patient-reported outcome instruments, including SARC-F, FACT-G, PSQI, PG-SGA, visual analogue scale pain score, and visual analogue scale appetite score. Patients will be followed for short-term clinical outcomes, including 30-day all-cause mortality, 90-day all-cause mortality, and 30-day unplanned hospital readmission after index discharge.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • •Adults aged 18 years and older
  • •Pathologically confirmed diagnosis of cancer
  • •Hospitalized with an expected hospital stay of more than 48 hours
  • •Ability to provide written informed consent

排除标准

  • •Diagnosis of anorexia nervosa
  • •Acute pancreatitis or acute liver failure at admission
  • •History of gastric bypass surgery
  • •Presence of chronic active infections
  • •History of solid organ transplantation
  • •Pregnant or breastfeeding women

研究组 & 干预措施

Hospitalized Cancer Patients

This cohort consists of adult patients (aged 18-80 years) with pathologically confirmed cancer who are admitted to the hospital for at least 48 hours. Hand grip strength is measured within the first 24 hours of admission using a standardized dynamometer protocol. Patients are followed prospectively for 30 days to evaluate primary and secondary outcomes including all-cause mortality, functional decline, hospital stay duration, readmission, and major complications.

干预措施: Hand Grip Strength Measurement (Other)

结局指标

主要结局

30-day All-Cause Mortality

时间窗: 30 days after hospital admission

All-cause mortality within 30 days of hospital admission among cancer patients (Yes/No). Mortality status will be assessed through hospital records and follow-up. Hand grip strength values will be analyzed in relation to mortality risk.

次要结局

  • Intensive Care Unit Admission(30 days after hospital admission)
  • Hospital Readmission(30 days after discharge)
  • Functional Decline - ECOG Performance Status(Baseline and 30 days after hospital admission)
  • Length of Hospital Stay(Through initial hospitalization, up to 30 days)
  • Major Complications(30 days after hospital admission)
  • Functional Decline - Patient-Generated Subjective Global Assessment (PG-SGA)(Baseline and 30 days after hospital admission)

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Galip Can Uyar

Medical Oncologist, Department of Medical Oncology

Ankara Etlik City Hospital

研究点 (1)

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