Study of Alterations in Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Measurement of muscle mitochondrial bioenergetics
研究概览
简要总结
Undernutrition associated with cancer, or cancer cachexia results from a deterioration of the energy balance that leads to a gradual mobilization of energy reserves in the body and to increasing deterioration of the nutritional status of patients. This will thus significantly reduce quality of life and survival of patients with a lower tolerance to cancer treatments. Despite undeniable progress in knowledge, many pathophysiological mechanisms remain few or not explored, which could explain that there is still no satisfactory therapeutic solution to halt the gradual deterioration of the nutritional status of patients. In this sense, apart from preclinical data obtained in animal models, there is currently no clinical study on the functioning of skeletal muscle energy metabolism in undernourished patients suffering of cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years ≤ Age ≤ 80 years
- •Colorectal pancreatic cancer
- •Undernutrition related to cancer (weight loss > 5% weight in one month or 10% in 6 months)
- •Indication to systemic chemotherapy
- •Indication to the development of an implantable port
- •Life expectancy ≥ 3 months
- •WHO General Status ≤ 2
- •Patients affiliated to social security scheme
- •Informed consent signed by the patient
排除标准
- •Pregnant or breastfeeding women
- •Unbalanced Diabetes
- •Systemic corticosteroid treatment
- •Any severe uncontrolled medical condition
- •Control group selection criteria:
- •Inclusion Criteria:
- •18 years ≤ Age ≤ 80 years
- •Colorectal pancreatic cancer
- •Indication adjuvant chemotherapy
- •Indication to the development of an implantable port
- •Life expectancy ≥ 3 months
- •WHO General Status ≤ 2
- •Patients affiliated to social security scheme
- •Informed consent signed by the patient
- •Exclusion Criteria:
- •Pregnant or breastfeeding women
- •Undernutrition related cancer (weight loss > 5% weight in one month or 10% in 6 months)
- •Unbalanced Diabetes
- •Systemic corticosteroid treatment
- •Any severe uncontrolled medical condition
研究组 & 干预措施
Case group
the intervention, specific to the study, is to take samples on patients with advanced gastrointestinal cancer
干预措施: Samples (Other)
Control group
the intervention, specific to the study, is to take samples on non-undernourished patients supported for adjuvant chemotherapy as part of colorectal cancer
干预措施: Samples (Other)
结局指标
主要结局
Measurement of muscle mitochondrial bioenergetics
时间窗: An average of one week
Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy
次要结局
- Quantification of muscle lipid droplets(An average of one week)
- Analysis of the expression of target genes and proteins(An average of one week)
- Determining the isotopic composition of nitrogen hair(An average of one week)
- Determination of body composition (fat mass / lean mass)(Within 4 weeks before inclusion)