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

Primary Purpose

Weight Loss, Ovarian Carcinoma, Endometrial Carcinoma

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Samples

About this trial

This is an interventional health services research trial for Weight Loss focused on measuring weight loss, ovarian cancer, endometrial cancer, energy metabolism, Body mass index, obesity, muscle energy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Gynecology Department, University Teaching Hospital, Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Case group

Control group

Arm Description

women with ovarian and/or endometrial cancer and weight loss will have muscle, adipose tissue, ovarian tumor and blood samples

women scheduled for an intervention for benign ovarian/ endometrial disease and no weight loss will have muscle, adipose tissue and blood samples

Outcomes

Primary Outcome Measures

Measurement of muscle mitochondrial bioenergetics according to BMI

Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy

Secondary Outcome Measures

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

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

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)

on computerized tomography

assessment of body composition (fat and muscle compartments)

Full Information

NCT ID

NCT03027479

First Posted

January 19, 2017

Last Updated

May 4, 2021

Sponsor

University Hospital, Tours

Collaborators

Inserm U1069 - Team Nutrition, Growth and Cancer

1. Study Identification

Unique Protocol Identification Number

NCT03027479

Brief Title

Skeletal Muscle Energy Metabolism in Women With Weight Loss and Ovarian and/or Endometrial Cancer With Weight Loss

Acronym

METERMUS-IMC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

July 16, 2019 (Actual)

Study Completion Date

July 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Tours

Collaborators

Inserm U1069 - Team Nutrition, Growth and Cancer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Loss, Ovarian Carcinoma, Endometrial Carcinoma

Keywords

weight loss, ovarian cancer, endometrial cancer, energy metabolism, Body mass index, obesity, muscle energy

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Case group

Arm Type

Experimental

Arm Description

women with ovarian and/or endometrial cancer and weight loss will have muscle, adipose tissue, ovarian tumor and blood samples

Arm Title

Control group

Arm Type

Other

Arm Description

women scheduled for an intervention for benign ovarian/ endometrial disease and no weight loss will have muscle, adipose tissue and blood samples

Intervention Type

Other

Intervention Name(s)

Samples

Intervention Description

Blood samples, muscle biopsy, adipose tissue samples and ovarian cancer tumor sample

Primary Outcome Measure Information:

Title

Measurement of muscle mitochondrial bioenergetics according to BMI

Description

Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy

Time Frame

muscle biopsy realized during surgery

Secondary Outcome Measure Information:

Title

on muscle biopsy

Description

Time Frame

muscle biopsy realized during surgery

Title

on white adipose tissue

Description

Time Frame

adipose tissue samples taken during surgery

Title

on ovarian cancer tumor samples

Description

Time Frame

ovarian tumor biopsies realized during surgery

Title

on computerized tomography

Description

assessment of body composition (fat and muscle compartments)

Time Frame

1 day of abdominal CT scan imaging procedure performed at diagnosis

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lobna OULDAMER, MD, PhD

Organizational Affiliation

University Teaching Hospital of Tours

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gynecology Department, University Teaching Hospital, Tours

City

Tours

ZIP/Postal Code

37044

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Skeletal Muscle Energy Metabolism in Women With Weight Loss and Ovarian and/or Endometrial Cancer With Weight Loss

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