Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer (METERMUCADIG)

September 25, 2019 updated by: University Hospital, Tours

Study of Alterations in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tours, France, 37044
        • Service d'Hépato-gastroentérologie et de Cancérologie Digestive, CHRU de TOURS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of muscle mitochondrial bioenergetics
Time Frame: An average of one week
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
Time Frame: An average of one week
Quantification of muscle lipid droplets by electron microscopy
An average of one week
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
An average of one week
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
Within 4 weeks before inclusion
Determining the isotopic composition of nitrogen hair
Time Frame: An average of one week
Determining the isotopic composition of nitrogen hair spectrometry .
An average of one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Collaborators

Inserm U1069 - Team Nutrition, Growth and Cancer

Investigators

  • Principal Investigator: Thierry LECOMTE, MD-PhD, University Hospital, Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2016

Primary Completion (Actual)

December 4, 2018

Study Completion (Actual)

December 4, 2018

Study Registration Dates

First Submitted

October 7, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHAO14-TL/METERMUCADIG
  • 2015-A00683-46 (Registry Identifier: IdRCB)
  • 2015-R25 (Other Identifier: CPP)
  • 150963B-12 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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