Skeletal Muscle Energy Metabolism in Women With Weight Loss and Ovarian and/or Endometrial Cancer With Weight Loss (METERMUS-IMC)

Study of Differences in Skeletal Muscle Energy Metabolism Alterations in Women With Weight Loss and Ovarian and/or Endometrial Cancer Based on the Body Mass Index

the aim is to study skeletal muscle metabolism alterations métaboliques associated with weight loss in women with ovarian and/or endometrial cancer according to BMI.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Endometrial Carcinoma; Ovarian Carcinoma
• Intervention / Treatment: Other: Samples

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • Gynecology Department, University Teaching Hospital, Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Case group selection criteria:

Inclusion Criteria:

• Women aged 18 years old and more
• Ovarian and/or endometrial cancer
• weight loss related to cancer (weight loss > 5% weight in one month or 10% in 6 months)
• Indication to therapeutic surgery
• Women affiliated to social security scheme
• Women who can understand French and able to sign Informed consent

Exclusion Criteria:

• Unbalanced Diabetes
• Chronic neuromuscular disorder
• Any severe uncontrolled medical condition

Control group selection criteria:

Inclusion Criteria:

• Women aged 18 years and more
• Surgery Indication for a benign endometrial and/ or ovarian disease
• Patient affiliated to social security scheme
• Women who can understand French and able to sign Informed consent

Exclusion Criteria:

• Unbalanced Diabetes
• Chronic neuromuscular disorder
• Any severe uncontrolled medical condition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Case group; women with ovarian and/or endometrial cancer and weight loss will have muscle, adipose tissue, ovarian tumor and blood samples	Other: Samples; Blood samples, muscle biopsy, adipose tissue samples and ovarian cancer tumor sample
Other: Control group; women scheduled for an intervention for benign ovarian/ endometrial disease and no weight loss will have muscle, adipose tissue and blood samples	Other: Samples; Blood samples, muscle biopsy, adipose tissue samples and ovarian cancer tumor sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of muscle mitochondrial bioenergetics according to BMI	Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy	muscle biopsy realized during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
on muscle biopsy	Quantification of lipids on electron microscope; Type of muscular fibers; Analyze of gene expression and proteins involved in 1/ Mitochondrial metabolism 2/ lipid metabolism and 3/ muscular proteolysis by RTqPCR with SyBR Green and Western Blot	muscle biopsy realized during surgery
on white adipose tissue	adipose tissue composition (fatty acids quantification, sterols, steroids); RT-qPCR quantification of molecules involved in lipid metabolism (synthesis, transport) and in inflammation (immune profile and cytokines); RTqPCR analysis, western blot and immunohistochemical expression of markers of transformation into brown adipose tissue; in specific milieu, in vitro experimentation on skeletal muscular cells	adipose tissue samples taken during surgery
on ovarian cancer tumor samples	lipid composition (fatty acids quantification, sterols, steroids); RT-qPCR quantification of molecules involved in lipid metabolism (synthesis, transport) and in inflammation (immune profil and cytokines); culture of tumour cells to evaluate resistance to chemotherapy (platinum)	ovarian tumor biopsies realized during surgery
on computerized tomography	assessment of body composition (fat and muscle compartments)	1 day of abdominal CT scan imaging procedure performed at diagnosis

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Collaborators: Inserm U1069 - Team Nutrition, Growth and Cancer
• Investigators: Principal Investigator: Lobna OULDAMER, MD, PhD, University Teaching Hospital of Tours

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): July 16, 2019
• Study Completion (Actual): July 16, 2019

Study Registration Dates

• First Submitted: January 19, 2017
• First Submitted That Met QC Criteria: January 20, 2017
• First Posted (Estimate): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: obesity; endometrial cancer; ovarian cancer; weight loss; energy metabolism; Body mass index; muscle energy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Body Weight Changes; Carcinoma; Weight Loss; Body Weight; Endometrial Neoplasms
• Other Study ID Numbers: PHAO16-LO/METERMUS-IMC; 2016-A01323-48 (Registry Identifier: IdRCB); 2016-R27 (Other Identifier: CPP)

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
• product manufactured in and exported from the U.S.: No