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

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

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.

Study Overview

• Status: Terminated
• Conditions: Cancer of Digestive System
• Intervention / Treatment: Diagnostic test: Height and weight; Diagnostic test: Blood samples; Diagnostic test: Skeletal muscle force; Diagnostic test: Skeletal muscle index; Diagnostic test: Muscle biopsy

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42055
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with digestive cancer requiring resection surgery; 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

Diagnostic test: Height and weight; Height and weight will be measured to estimate cachexia degree at the time of anaesthetic consultation. (V1); Diagnostic test: 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); Diagnostic test: 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); Diagnostic test: 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); Diagnostic test: Muscle biopsy; Muscle biopsy will be performed during resection surgery under general anaesthesia. (V2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Karine ABBOUD, MD, CHU de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2018
• Primary Completion (Actual): January 3, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 29, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Cachexia; Skeletal muscle; Myostatin; Cancer of Digestive System
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Neoplasms; Neoplasms by Site; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Digestive System Neoplasms; Wasting Syndrome; Cachexia
• Other Study ID Numbers: 1708054; ANSM (Other Identifier: 2022-A02513-40)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No