Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia (MYOCAC)

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: Cancer of Digestive System

Treatments: Diagnostic Test: Blood samples; Diagnostic Test: Height and weight; Diagnostic Test: Muscle biopsy; Diagnostic Test: Skeletal muscle index; Diagnostic Test: Skeletal muscle force

Study type: Interventional

Funder types: Other

Identifiers

NCT03172403

1708054

ANSM (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Patients with digestive cancer requiring resection surgery

Experimental group

Description:

Patients with cancer of digestive system requiring resection surgery will be included. They will have measure of height and weight, blood samples, skeletal muscle force, skeletal muscle index and muscle biopsy. V1: Inclusion will be effectuated at the time of anaesthetic consultation V2: The day before and day of resection surgery about 1 month after V3: Follow-up at 1 month V4: Follow-up at 3 months V6: Follow-up at 6 months

Treatment:

Diagnostic Test: Muscle biopsy

Diagnostic Test: Skeletal muscle index

Diagnostic Test: Height and weight

Diagnostic Test: Blood samples

Diagnostic Test: Skeletal muscle force