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NCT Number: NCT02573974

Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer

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.

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Key information

Conditions

Undernutrition Digestive System Diseases Digestive System Neoplasms Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Malnutrition Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'Hépato-gastroentérologie et de Cancérologie Digestive, CHRU de TOURS

Tours, 37044, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Samples

Other

Blood samples, muscle biopsy and sample of hair

Primary outcomes

  1. Measurement of muscle mitochondrial bioenergetics

    Time frame: An average of one week

    Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy

Secondary outcomes

  1. Quantification of muscle lipid droplets

    Time frame: An average of one week

    Quantification of muscle lipid droplets by electron microscopy

  2. Analysis of the expression of target genes and proteins

    Time frame: 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

  3. Determination of body composition (fat mass / lean mass)

    Time frame: Within 4 weeks before inclusion

    Determination of body composition ( fat mass / lean mass ) by an imaging method scannographic

  4. Determining the isotopic composition of nitrogen hair

    Time frame: An average of one week

    Determining the isotopic composition of nitrogen hair spectrometry .

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Collaborators

  • Inserm U1069 - Team Nutrition, Growth and Cancer

Registry information

Official study title

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

Acronym: METERMUCADIG

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 12, 2015
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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