Prospective Study of Detection of Sarcopenia in Clinical Practice for Patient With Ovarian or Endometrial Cancer
NCT ID: NCT05833321
Last Updated: 2023-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
75 participants
INTERVENTIONAL
2022-11-20
2026-10-31
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
* 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 Non-inclusion 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
Study Groups
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Interventionnal
"Hand Grip" Dynamometer Walk test SEFI Nutritional Intake Assessment Questionnaire
Sarcopenia diagnostic test
measurement of impedance and physical tests ("hand grip" dynamometer, walking test), SEFI nutritional intake questionnaire
Interventions
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Sarcopenia diagnostic test
measurement of impedance and physical tests ("hand grip" dynamometer, walking test), SEFI nutritional intake questionnaire
Eligibility Criteria
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Inclusion Criteria
* 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 endometrial cancer not requiring chemotherapy treatment
* Discovery of an intercurrent cancer other than skin or cervix cancers.
* Patient wearing a Pace maker
18 Years
FEMALE
No
Sponsors
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Centre Hospitalier Metropole Savoie
OTHER
Responsible Party
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Principal Investigators
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fillon aurélie
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Metropole Savoie
Locations
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Centre Hospitalier Metropole Savoie
Chambéry, Savoie, France
Countries
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Central Contacts
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Facility Contacts
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jego florence, ARC
Role: primary
Other Identifiers
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CHMS22005
Identifier Type: -
Identifier Source: org_study_id
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