METERMUCADIG: Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer

Sponsor

University Hospital, Tours (Other)

Overall Status

Completed

CT.gov ID

NCT02573974

Collaborator

Inserm U1069 - Team Nutrition, Growth and Cancer (Other)

Enrollment

Location

Arms

34.5

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Undernutrition Gastrointestinal Cancer	Other: Samples	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Jan 19, 2016

Actual Primary Completion Date :

Dec 4, 2018

Actual Study Completion Date :

Dec 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Case group the intervention, specific to the study, is to take samples on patients with advanced gastrointestinal cancer	Other: Samples Blood samples, muscle biopsy and sample of hair
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	Other: Samples Blood samples, muscle biopsy and sample of hair

Arm

Intervention/Treatment

Other: Case group

the intervention, specific to the study, is to take samples on patients with advanced gastrointestinal cancer

Other: Samples

Blood samples, muscle biopsy and sample of hair

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

Other: Samples

Blood samples, muscle biopsy and sample of hair

Outcome Measures

Primary Outcome Measures

Measurement of muscle mitochondrial bioenergetics [An average of one week]
Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy

Secondary Outcome Measures

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
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
Determining the isotopic composition of nitrogen hair [An average of one week]
Determining the isotopic composition of nitrogen hair spectrometry .

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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