Ovarian Neoplasms, Sarcopenia
Conditions
Brief summary
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_TESTSarcopenia diagnostic test
measurement of impedance and physical tests (hand grip dynamometer, walking test), SEFI nutritional intake questionnaire
Sponsors
Centre Hospitalier Metropole Savoie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
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 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
Intervention model description
prospective non-randomized interventional study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical screening for sarcopenia | 36 month | 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. |
| Proposal of a composite score for the detection of sarcopenia usable in clinical routine | 36 month | Statistical analysis of sarcopenia and undernutrition data |
Countries
France
Contacts
Primary Contactjego florence
Outcome results
None listed