Prospective Study of Detection of Sarcopenia in Clinical Practice for Patient With Ovarian or Endometrial Cancer — SARCO-GYN  

Sarcopenia Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Ovarian Neoplasms
• Sarcopenia

• NCT number: NCT05833321
• Study type: Interventional
• Source: Centre Hospitalier Metropole Savoie
• Contact: jego florence
• Phone: 0479965813
• Email: florence.jego@ch-metropole-savoie.fr
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2022
• Completion date: October 2026