Prospective Study of Detection of Sarcopenia in Clinical Practice for Patient With Ovarian or Endometrial Cancer

Study Overview
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Brief Summary
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Prospective monocentric study, non-randomized of the detection of sarcopenia in clinical practice in patients with ovarian or endometrial cancer requiring systemic oncological treatment. main question : Identify the criteria correlated with the presence of sarcopenia (defined by the measurement of the IMS by the CT-X method in L3) among the impedancemetry and the HAS malnutrition criteria. Data collection will be done at 6 months, 12 months after the date of inclusion.

Detailed Description
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Primary objective:Identify the criteria correlated to the presence of sarcopenia (defined by the measurement of the IMS by the CT-X method in L3) among the impedancemetry and the HAS malnutrition criteria Main judgment criteria : Comparison between the groups of patients with sarcopenia (Morphometric measurement of the musculoskeletal surface index <39cm²/m² in L3 cross section) and without sarcopenia of the different evaluation criteria: Impedancemetry values:: muscle mass index in kg/m2 (IMS), fat-free mass in kg/m2 and metabolic activity index (phase angle) Percentage of weight loss BMI < 18.5 kg/m2 Quantified reduction in muscle mass and/or function for patients < 70 years old Quantified reduction in muscle mass and function for patients > 70 years old Physical tests: walking speed and hand grip dynamometer secondary objectives:- Proposal of a composite score for the detection of sarcopenia usable in clinical routine Evaluation of nutritional intake Evaluation of the severity of undernutrition Verification of a correlation between the sarcopenia indices of ovarian and endometrial cancer Evaluate tolerance profiles to systemic treatments with regard to sarcopenia figures Assess the relationship between PFS, OS and sarcopenia index in cancer diagnosis secondary judgment criteria : Statistical analysis of sarcopenia and undernutrition data Quantification of ingestates (SEFI scale) +/- intake of oral nutritional supplement Serological tests: NFS, CRP and Albuminemia Comparison of sarcopenia index figures between ovarian and endometrial cancer Collection of the grades of toxicities and adverse events to systemic treatments in parallel with the measurement of sarcopenia. Correlation between progression-free survival, death and sarcopenia index at cancer diagnosis

Official Title
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Prospective Monocentric Study of the Detection of Sarcopenia in Clinical Practice in Patients With Ovarian or Endometrial Cancer Requiring Systemic Oncological Treatment

Conditions
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Ovarian Neoplasms, Sarcopenia

Intervention / Treatment
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* Diagnostic Test: Sarcopenia diagnostic test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at least 18 years old Patient presenting with a diagnosis of cancer of ovarian origin with an indication for chemotherapy Patient with a diagnosis of endometrial cancer with an indication for chemotherapy Patient with no diagnosis of other types of cancer in the previous five years Collection of consent Patient affiliated to a Social Security scheme Exclusion Criteria: Patient with cancer of ovarian origin not requiring chemotherapy treatment Patient with endometrial cancer not requiring chemotherapy treatment Discovery of an intercurrent cancer other than skin or cervix cancers. Patient wearing a Pace maker

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: prospective non-randomized interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventionnal<br>Hand Grip Dynamometer Walk test SEFI Nutritional Intake Assessment Questionnaire | Diagnostic Test: Sarcopenia diagnostic test<br>* measurement of impedance and physical tests (hand grip dynamometer, walking test), SEFI nutritional intake questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical screening for sarcopenia | Identify the criteria correlated with the presence of sarcopenia (defined by the measurement of the IMS by the CT-X method in L3) among the impedancemetry and the HAS malnutrition criteria. | 36 month | 
| Proposal of a composite score for the detection of sarcopenia usable in clinical routine | Statistical analysis of sarcopenia and undernutrition data | 36 month |