Prognostic Role of Muscle Dysfunction in Patients With Gastrointestinal or Hepatobiliary Cancer - An Observational Study of Two Patient Cohorts
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Cohort 1: Post-operative complications
研究概览
简要总结
PURPOSE: To determine the prognostic properties of a comprehensive evaluation of body composition and physical function in patients with GI-HEP cancer from point of diagnosis and throughout the treatment trajectory.
GI-HEP: Patients with tumors of the upper gastrointestinal or hepatobiliary tract, specifically tumors of the esophagus, gastro-esophageal junction, stomach, primary tumors of the liver or biliary tract, as well as colorectal liver metastasis or tumors of the pancreas.
详细描述
RATIONAL: Patients diagnosed with GI-HEP cancer are faced with poor prognosis. The treatment is demanding and associated with severe deconditioning potentially leading to worse prognostic outcomes. To what extend patients body composition at the point of diagnoses, as well as changes in body composition throughout the cancer continuum is associated with cancer outcomes is currently not well-described, specifically if this should be part of standard clinical evaluation in order to optimize therapy-efficacy. Recent findings suggest that pathophysiological alterations in skeletal muscle mass and function can have significant implications for the risk of disease progression and long-term prognosis.
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
- •Patients diagnosed with histologically verified GI-HEP cancer
排除标准
- •Age: <18
- •Pregnancy
- •Physical or mental disabilities precluding physical testing
- •Inability to read and understand Danish
结局指标
主要结局
Cohort 1: Post-operative complications
时间窗: From baseline to 30 days post surgery
Incidens rate of post-operative complications (Clavien-Dindo grade 2 or higher).
Cohort 2: Medical treatment complications
时间窗: From baseline to 1 year follow-up
Incidens rate of medical complications (dose-reduction, temporary or permanent discontinuation)
次要结局
- Change in sleep quality(From baseline to 6 months follow-up)
- Overall survival(From baseline to 1 year follow-up)
- Change in whole body fat percentage(From baseline to 6 months follow-up)
- Hospitalization duration(From baseline to 1 year follow-up)
- Disease free survival(From baseline to 1 year follow-up)
- Change in bone mineral content(From baseline to 6 months follow-up)
- Change in Skeletal Muscle Index(From baseline to 6 months follow-up)
- Change in lower body physical function(From baseline to 6 months follow-up)
- Change in maximum leg power(From baseline to 6 months follow-up)
- Change in hand grip strength(From baseline to 6 months follow-up)
- Change in plasma HbA1C(From baseline to 6 months follow-up)
- Change in psychological distress(From baseline to 6 months follow-up)
- Change in physical activity level(From baseline to 6 months follow-up)
- Change in whole body lean mass(From baseline to 6 months follow-up)
- Change in visceral fat mass(From baseline to 6 months follow-up)
- Change in bone mineral density(From baseline to 6 months follow-up)
- Change in plasma total cholesterol concentration(From baseline to 6 months follow-up)
- Change in plasma HDL cholesterol(From baseline to 6 months follow-up)
- Change in plasma glucose(From baseline to 6 months follow-up)
- Change in appendicular lean mass(From baseline to 6 months follow-up)
- Change in stair-climbing capacity(From baseline to 6 months follow-up)
- Change in plasma triglycerides(From baseline to 6 months follow-up)
- Change in plasma insulin(From baseline to 6 months follow-up)
- Change in plasma LDL cholesterol(From baseline to 6 months follow-up)
- Change in Walking capacity(From baseline to 6 months follow-up)
- Change in health-related quality of life(From baseline to 6 months follow-up)
研究者
Jesper Frank Christensen, PhD
Senior researcher
Rigshospitalet, Denmark