Prospective Study of Detection of Sarcopenia in Clinical Practice for Patient With Ovarian or Endometrial Cancer

Sarcopenia Clinical Trial

— SARCO-GYN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05833321
• Other study ID #: CHMS22005
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2022
• Est. completion date: October 2026

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Metropole Savoie
• Contact: jego florence
• Phone: 0479965813
• Email: florence.jego[@]ch-metropole-savoie.fr
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: October 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Ovarian Neoplasms
• Sarcopenia

Intervention

Diagnostic Test:
• Sarcopenia diagnostic test
measurement of impedance and physical tests ("hand grip" dynamometer, walking test), SEFI nutritional intake questionnaire

Locations

Country	Name	City	State
France	Centre Hospitalier Metropole Savoie	Chambéry	Savoie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Metropole Savoie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical screening for sarcopenia	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.	36 month
Primary	Proposal of a composite score for the detection of sarcopenia usable in clinical routine	Statistical analysis of sarcopenia and undernutrition data	36 month