Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia

Cancer of Digestive System Clinical Trial

— MYOCAC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03172403
• Other study ID #: 1708054
• Secondary ID: ANSM
• Status: Terminated
• Phase: N/A
• Start date: August 2, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: August 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 1, 2019
• Est. primary completion date: January 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Cancer of Digestive System
• Digestive System Neoplasms

Intervention

Diagnostic Test:
• Height and weight
Height and weight will be measured to estimate cachexia degree at the time of anaesthetic consultation. (V1)
• Blood samples
Blood samples will be collected for measuring myostatin on blood at the time of anaesthetic consultation, the day before resection surgery, follow-ups at 1, 3 and 6 months. (V1, V2, V3, V4, V6)
• Skeletal muscle force
Skeletal muscle force will be determined from Computerized Tomography (CT)-scan at the time of anaesthetic, follow-ups at 1, 3 and 6 months. (V1, V3, V4, V6)
• Skeletal muscle index
Skeletal muscle index will be determined from Computerized Tomography (CT)-scan at the time of anaesthetic, follow-ups at 1, 3 and 6 months. (V1, V3, V4, V6)
• Muscle biopsy
Muscle biopsy will be performed during resection surgery under general anaesthesia. (V2)

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between skeletal muscle and degree myostatin	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.	Day 1
Secondary	Correlation between skeletal muscle force and index before resection surgery	Evaluate Correlation between skeletal muscle force and index before resection surgery to estimate the extent of cachexia-induced muscle dysfunction by results tests.	Baseline from 7 months
Secondary	Correlation between level of myostatin muscular expression and degree myostatin	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.	Month 2
Secondary	Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery	Determinate correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery.	Month 2
Secondary	Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery	Determinate correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery.	Month 4
Secondary	Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery	Determinate correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery.	Month 7
Secondary	Analysis level of myostatin muscular expression and blood samples results	Analysis level of myostatin muscular expression and blood samples results according to cancer stage, neoadjuvant treatment and chemotherapy.	Month 2