Prospective Study of Detection of Sarcopenia in Clinical Practice for Patient With Ovarian or Endometrial Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sarcopenia diagnostic test.
- Who it may be relevant to
- Registry conditions: Ovarian Neoplasms, Sarcopenia. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Monocentric Study of the Detection of Sarcopenia in Clinical Practice in Patients With Ovarian or Endometrial Cancer Requiring Systemic Oncological Treatment
Overview
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
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
Interventions
- Diagnostic test Sarcopenia diagnostic test
measurement of impedance and physical tests ("hand grip" dynamometer, walking test), SEFI nutritional intake questionnaire
Primary outcome measures
- clinical screening for sarcopenia [Time frame: 36 month]
- Proposal of a composite score for the detection of sarcopenia usable in clinical routine [Time frame: 36 month]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Centre Hospitalier Metropole Savoie — Chambéry
Identifiers
NCT: NCT05833321 · CHMS22005