Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer

Gastrointestinal Cancer Clinical Trial

— METERMUCADIG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02573974
• Other study ID #: PHAO14-TL/METERMUCADIG
• Secondary ID: 2015-A00683-4620
• Status: Completed
• Phase: N/A
• Start date: January 19, 2016
• Est. completion date: December 4, 2018

Study information

• Verified date: September 2019
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 4, 2018
• Est. primary completion date: December 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Malnutrition
• Undernutrition

Intervention

Other:
• Samples
Blood samples, muscle biopsy and sample of hair

Locations

Country	Name	City	State
France	Service d'Hépato-gastroentérologie et de Cancérologie Digestive, CHRU de TOURS	Tours

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Tours	Inserm U1069 - Team Nutrition, Growth and Cancer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of muscle mitochondrial bioenergetics	Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy	An average of one week
Secondary	Quantification of muscle lipid droplets	Quantification of muscle lipid droplets by electron microscopy	An average of one week
Secondary	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	An average of one week
Secondary	Determination of body composition (fat mass / lean mass)	Determination of body composition ( fat mass / lean mass ) by an imaging method scannographic	Within 4 weeks before inclusion
Secondary	Determining the isotopic composition of nitrogen hair	Determining the isotopic composition of nitrogen hair spectrometry .	An average of one week