Prospective Monocentric Study of the Detection of Sarcopenia in Clinical Practice in Patients With Ovarian or Endometrial Cancer Requiring Systemic Oncological Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ovarian Neoplasms
- Sponsor
- Centre Hospitalier Metropole Savoie
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Proposal of a composite score for the detection of sarcopenia usable in clinical routine
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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
Investigators
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
Outcomes
Primary Outcomes
Proposal of a composite score for the detection of sarcopenia usable in clinical routine
Time Frame: 36 month
Statistical analysis of sarcopenia and undernutrition data
clinical screening for sarcopenia
Time Frame: 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.