Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Study of Alterations in Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer

Conditions
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Undernutrition, Gastrointestinal Cancer

Intervention / Treatment
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* Other: Samples


Participation Criteria
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Eligibility Criteria
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Case group selection criteria: Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Case group<br>the intervention, specific to the study, is to take samples on patients with advanced gastrointestinal cancer | Other: Samples<br>* Blood samples, muscle biopsy and sample of hair<br>|
| Other: Control group<br>the intervention, specific to the study, is to take samples on non-undernourished patients supported for adjuvant chemotherapy as part of colorectal cancer | Other: Samples<br>* Blood samples, muscle biopsy and sample of hair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of muscle mitochondrial bioenergetics | Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy | An average of one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of muscle lipid droplets | Quantification of muscle lipid droplets by electron microscopy | An average of one week | 
| Analysis of the expression of target genes and proteins | 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 | An average of one week | 
| Determination of body composition (fat mass / lean mass) | Determination of body composition ( fat mass / lean mass ) by an imaging method scannographic | Within 4 weeks before inclusion | 
| Determining the isotopic composition of nitrogen hair | Determining the isotopic composition of nitrogen hair spectrometry . | An average of one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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undernutrition, gastrointestinal cancer, skeletal muscle, energy metabolism