Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia
- Conditions
- Cancer of Digestive System
- Interventions
- Diagnostic Test: Height and weightDiagnostic Test: Blood samplesDiagnostic Test: Skeletal muscle forceDiagnostic Test: Skeletal muscle indexDiagnostic Test: Muscle biopsy
- Registration Number
- NCT03172403
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with digestive cancer requiring resection surgery Height and weight 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 Patients with digestive cancer requiring resection surgery Skeletal muscle force 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 Patients with digestive cancer requiring resection surgery Blood samples 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 Patients with digestive cancer requiring resection surgery Skeletal muscle index 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 Patients with digestive cancer requiring resection surgery Muscle biopsy 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
- Primary Outcome Measures
Name Time Method Correlation between skeletal muscle and degree myostatin Day 1 Evaluate correlation between skeletal muscle force/index and degree myostatin. Skeletal muscle force/index will be determinated by skeletal muscle force/index results.
Degree myostatin will be determinated by blood samples with Enzyme Linked ImmunoSorbent Assay (ELISA) method.
- Secondary Outcome Measures
Name Time Method Correlation between skeletal muscle force and index before resection surgery Baseline from 7 months Evaluate Correlation between skeletal muscle force and index before resection surgery to estimate the extent of cachexia-induced muscle dysfunction by results tests.
Correlation between level of myostatin muscular expression and degree myostatin Month 2 Evaluate correlation between level of myostatin muscular expression and degree myostatin.
Level of myostatin muscular expression will be determinated by muscle biopsy. Degree myostatin will be determinated by blood samples with Enzyme Linked ImmunoSorbent Assay (ELISA) method.Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery Month 7 Determinate correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery.
Analysis level of myostatin muscular expression and blood samples results Month 2 Analysis level of myostatin muscular expression and blood samples results according to cancer stage, neoadjuvant treatment and chemotherapy.
Trial Locations
- Locations (1)
CHU Saint-Etienne
🇫🇷Saint-Étienne, France