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

Primary Purpose

Undernutrition, Gastrointestinal Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Samples
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Undernutrition focused on measuring undernutrition, gastrointestinal cancer, skeletal muscle, energy metabolism

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Case group

Control group

Arm Description

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

the intervention, specific to the study, is to take samples on non-undernourished patients supported for adjuvant chemotherapy as part of colorectal cancer

Outcomes

Primary Outcome Measures

Measurement of muscle mitochondrial bioenergetics
Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy

Secondary Outcome Measures

Quantification of muscle lipid droplets
Quantification of muscle lipid droplets by electron microscopy
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
Determination of body composition (fat mass / lean mass)
Determination of body composition ( fat mass / lean mass ) by an imaging method scannographic
Determining the isotopic composition of nitrogen hair
Determining the isotopic composition of nitrogen hair spectrometry .

Full Information

First Posted
October 7, 2015
Last Updated
September 25, 2019
Sponsor
University Hospital, Tours
Collaborators
Inserm U1069 - Team Nutrition, Growth and Cancer
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1. Study Identification

Unique Protocol Identification Number
NCT02573974
Brief Title
Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer
Acronym
METERMUCADIG
Official Title
Study of Alterations in Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 19, 2016 (Actual)
Primary Completion Date
December 4, 2018 (Actual)
Study Completion Date
December 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
Collaborators
Inserm U1069 - Team Nutrition, Growth and Cancer

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undernutrition, Gastrointestinal Cancer
Keywords
undernutrition, gastrointestinal cancer, skeletal muscle, energy metabolism

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Case group
Arm Type
Other
Arm Description
the intervention, specific to the study, is to take samples on patients with advanced gastrointestinal cancer
Arm Title
Control group
Arm Type
Other
Arm Description
the intervention, specific to the study, is to take samples on non-undernourished patients supported for adjuvant chemotherapy as part of colorectal cancer
Intervention Type
Other
Intervention Name(s)
Samples
Intervention Description
Blood samples, muscle biopsy and sample of hair
Primary Outcome Measure Information:
Title
Measurement of muscle mitochondrial bioenergetics
Description
Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy
Time Frame
An average of one week
Secondary Outcome Measure Information:
Title
Quantification of muscle lipid droplets
Description
Quantification of muscle lipid droplets by electron microscopy
Time Frame
An average of one week
Title
Analysis of the expression of target genes and proteins
Description
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
Time Frame
An average of one week
Title
Determination of body composition (fat mass / lean mass)
Description
Determination of body composition ( fat mass / lean mass ) by an imaging method scannographic
Time Frame
Within 4 weeks before inclusion
Title
Determining the isotopic composition of nitrogen hair
Description
Determining the isotopic composition of nitrogen hair spectrometry .
Time Frame
An average of one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry LECOMTE, MD-PhD
Organizational Affiliation
University Hospital, Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Hépato-gastroentérologie et de Cancérologie Digestive, CHRU de TOURS
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35316572
Citation
Dolly A, Lecomte T, Tabchouri N, Caulet M, Michot N, Anon B, Chautard R, Desvignes Y, Ouaissi M, Fromont-Hankard G, Dumas JF, Servais S. Pectoralis major muscle atrophy is associated with mitochondrial energy wasting in cachectic patients with gastrointestinal cancer. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1837-1849. doi: 10.1002/jcsm.12984. Epub 2022 Mar 22.
Results Reference
derived

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Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer

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