Structural Characteristics of Trunk and Limb Muscles in Cachectic Colorectal Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Mitochondrial morphology
研究概览
简要总结
Until now, cancer is still associated with high morbidity and mortality, and is therefore a big issue for the public health. Colorectal cancer is the second leading cause of cancer death in developed countries. In advanced colorectal cancer, 60% of these patients develop cachexia. The presence of cachexia plays an important role in the high mortality rate of cancer. Cachexia is characterized by involuntary weight loss with loss of skeletal muscle with or without loss of fat mass.
The aim of this study is to determine the feasibility of taking muscle biopsies of cachectic colorectal cancer patients. Skeletal muscle characteristics will be compared between biopsies of the m. erector spinae and the m. vastus lateralis from cachectic colorectal cancer patients, non-cachectic colorectal cancer patients and healthy controls.
10 cachectic, 25 non-cachectic, and 25 healthy controls will be recruited for this study. It is an observational study, so measurements will be taken at one time point. Interventions/measurements:
- muscle biopsies
- blood samples
- 3D freehand ultrasound
- Short physical performance battery test
- handgrip strength
- questionnaires (activity pattern, quality of life)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Mental of psychological condition
- •Insufficient knowledge of the Dutch language
- •Muscle diseases affecting the spine and lower limbs
- •Bedridden
- •Non-Cachectic cancer patients.
- •Inclusion criteria:
- •minimum age of 18 years old
- •No unwanted weight loss > 5% in the last 6 months OR > 2% unwanted weight loss in combination with a BMI < 20kg/m2 OR >2% unwanted weight loss in combination with sarcopenia
- •Cachexia staging score (CSS): 0-2
- •Exclusion criteria:
- •Mental of psychological condition
- •Insufficient knowledge of the Dutch language
- •Muscle diseases affecting the spine and lower limbs
- •Bedridden
- •Healthy controls.
- •Inclusion criteria:
- •- minimum age of 18 years old
- •Exclusion criteria:
- •Mental of psychological condition
- •Insufficient knowledge of the Dutch language
- •Muscle diseases affecting the spine and lower limbs
- •Bedridden
结局指标
主要结局
Mitochondrial morphology
时间窗: at enrollment
mitochondrial fusion and fission (western blot) mitochondrial OXPHOS (western blot)
Skeletal muscle fiber typing
时间窗: at enrollment
Immunofluorescence staining of skeletal muscle biopsies to observe different muscle fiber types (myosin heavy chains)
skeletal muscle nuclei
时间窗: at enrollment
Immunofluorescence staining with DAPI
Inflammatory parameters
时间窗: at enrollment
ELISA (bloodsamples), immunofluorescence staining (muscle biopsies)
次要结局
- 3D freehand ultrasound(at enrollment)
- CT-scans(at enrollment)
- Quality of Life questionnaire(at enrollment)
- skeletal muscle capillarization(at enrollment)
- Activity pattern(at enrollment)
- VAS score(at enrollment)
- Handgrip strength(at enrollment)
- Short Physical Performance Battery (SPPB) test(at enrollment)
研究者
prof. dr. Kenneth Verboven
Prof. dr.
Hasselt University