Clinical trial NCT02573974: Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer
Official title: Study of Alterations in Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Undernutrition
Gastrointestinal Cancer
Keywords: undernutrition
gastrointestinal cancer
skeletal muscle
energy metabolism
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Inserm U1069 - Team Nutrition, Growth and Cancer
First posted: 2015-10-12
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Measurement of muscle mitochondrial bioenergetics
timeFrame: An average of one week
Secondary outcomes:
measure: Quantification of muscle lipid droplets
timeFrame: An average of one week
measure: Analysis of the expression of target genes and proteins
timeFrame: An average of one week
measure: Determination of body composition (fat mass / lean mass)
timeFrame: Within 4 weeks before inclusion
measure: Determining the isotopic composition of nitrogen hair
timeFrame: An average of one week
Other outcomes:
Locations:
city: Tours
country: France
facility: Service d'Hépato-gastroentérologie et de Cancérologie Digestive, CHRU de TOURS
Study officials:
affiliation: University Hospital, Tours
name: Thierry LECOMTE, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.