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

Not Applicable

Completed

• Conditions: Weight Loss; Ovarian Carcinoma; Endometrial Carcinoma

• Registration Number: NCT03027479
• Lead Sponsor: University Hospital, Tours

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-19
• Study First Submitted QC: 2017-01-20
• Study First Posted: 2017-01-23
• Study Start: 2017-03-01
• Primary Completion: 2019-07-16
• Study Completion: 2019-07-16
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Measurement of muscle mitochondrial bioenergetics according to BMI	muscle biopsy realized during surgery	Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy

Secondary Outcome Measures

Name	Time	Method
on muscle biopsy	muscle biopsy realized during surgery	* 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 ovarian cancer tumor samples	ovarian tumor biopsies realized during surgery	* 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 white adipose tissue	adipose tissue samples taken during surgery	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 computerized tomography	1 day of abdominal CT scan imaging procedure performed at diagnosis	assessment of body composition (fat and muscle compartments)

Trial Locations

Locations (1)

Gynecology Department, University Teaching Hospital, Tours; 🇫🇷 Tours, France