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Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02573974
Acronym
METERMUCADIG
Enrollment
51
Registered
2015-10-12
Start date
2016-01-19
Completion date
2018-12-04
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Cancer, Undernutrition

Keywords

undernutrition, gastrointestinal cancer, skeletal muscle, energy metabolism

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.

Interventions

OTHERSamples

Blood samples, muscle biopsy and sample of hair

Sponsors

Inserm U1069 - Team Nutrition, Growth and Cancer
CollaboratorUNKNOWN
University Hospital, Tours
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of muscle mitochondrial bioenergeticsAn average of one weekMeasurement of muscle mitochondrial bioenergetics by high resolution oxygraphy

Secondary

MeasureTime frameDescription
Quantification of muscle lipid dropletsAn average of one weekQuantification of muscle lipid droplets by electron microscopy
Analysis of the expression of target genes and proteinsAn average of one weekAnalysis 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 inclusionDetermination of body composition ( fat mass / lean mass ) by an imaging method scannographic
Determining the isotopic composition of nitrogen hairAn average of one weekDetermining the isotopic composition of nitrogen hair spectrometry .

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026