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

Centre Hospitalier Metropole Savoie

Status: Enrolling

Conditions: Ovarian Neoplasms; Sarcopenia

Treatments: Diagnostic Test: Sarcopenia diagnostic test

Study type: Interventional

Funder types: Other

Identifiers

NCT05833321

CHMS22005

Details and patient eligibility

About

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.

Full 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

Enrollment: 75 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Interventionnal

Experimental group

Description:

"Hand Grip" Dynamometer Walk test SEFI Nutritional Intake Assessment Questionnaire

Treatment:

Diagnostic Test: Sarcopenia diagnostic test