Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer
- Conditions
- UndernutritionGastrointestinal Cancer
- Interventions
- Other: Samples
- Registration Number
- NCT02573974
- Lead Sponsor
- University Hospital, Tours
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- 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
- Pregnant or breastfeeding women
- Unbalanced Diabetes
- Systemic corticosteroid treatment
- Any severe uncontrolled medical condition
- Alopecia
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
- Alopecia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Case group Samples the intervention, specific to the study, is to take samples on patients with advanced gastrointestinal cancer Control group Samples the intervention, specific to the study, is to take samples on non-undernourished patients supported for adjuvant chemotherapy as part of colorectal cancer
- Primary Outcome Measures
Name Time Method Measurement of muscle mitochondrial bioenergetics An average of one week Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy
- Secondary Outcome Measures
Name Time Method Quantification of muscle lipid droplets An average of one week Quantification of muscle lipid droplets by electron microscopy
Analysis of the expression of target genes and proteins An average of one week Analysis of the expression of target genes and proteins involved in 1/ mitochondrial metabolism 2/ lipid metabolism 3/ the regulation of energy metabolism and 4/ muscle proteolysis by RTqPCR with SYBR Green and by Western Blot
Determining the isotopic composition of nitrogen hair An average of one week Determining the isotopic composition of nitrogen hair spectrometry .
Determination of body composition (fat mass / lean mass) Within 4 weeks before inclusion Determination of body composition ( fat mass / lean mass ) by an imaging method scannographic
Trial Locations
- Locations (1)
Service d'Hépato-gastroentérologie et de Cancérologie Digestive, CHRU de TOURS
🇫🇷Tours, France