Clinical trial NCT03172403: Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia
Official title: Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia(MYOCAC Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer of Digestive System
Keywords: Cachexia
Cancer of Digestive System
Myostatin
Skeletal muscle
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 3
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Cancer cachexia is responsible for the death of approximately 20% of patients. Myostatin is a master negative regulator of skeletal muscle mass. If the role of myostatin in cancer cachexia is now well established in murine models, no study has focused on muscle expression of Myostatin in relation to the degree of cachexia. the hypothesize is that muscle Myostatin a biological marker of cachexia in patients with cancer of digestive system. The main objective is to compare skeletal muscle Myostatin messenger RiboNucleic Acid (mRNA) level as a function of cachexia in cancer of digestive system patients. Myostatin messenger RiboNucleic Acid (mRNA) level will be determined in a muscle sample taken during the resection under general anaesthesia. Skeletal muscle index will be determined before surgery, 3 and 6 months after surgery. Muscle strength of the lower and upper limbs will be determined before resection, at 1 month, 3 months and 6 months postoperatively. Blood sampling will also be performed on these 4 occasions.


Eligibility criteria: Inclusion Criteria:

* Women and men aged 40-80.
* Diagnosis for cancer of digestive system requiring surgery with neoadjuvant treatment or not.
* Signature of consent
* Affiliate or beneficiary of social security

Exclusion Criteria:

* Administration of corticosteroids.
* Thyroid disease treated.
* Severe chronic pathology during treatment (neuro-muscular pathologies, renal insufficiency requiring dialysis, COPD under continuous oxygen therapy).
* Psychological, familial, social or geographical conditions that could affect the participation of the subject throughout the duration of the protocol.
* BMI\> 30 due to the difficulty of interpretation of BMI variations in obese patients

Primary outcomes:
measure: Correlation between skeletal muscle and degree myostatin
timeFrame: Day 1
Secondary outcomes:
measure: Correlation between skeletal muscle force and index before resection surgery
timeFrame: Baseline from 7 months
measure: Correlation between level of myostatin muscular expression and degree myostatin
timeFrame: Month 2
measure: Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery
timeFrame: Month 2
measure: Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery
timeFrame: Month 4
measure: Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery
timeFrame: Month 7
measure: Analysis level of myostatin muscular expression and blood samples results
timeFrame: Month 2
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Karine ABBOUD, MD
role: PRINCIPAL_INVESTIGATOR
References: