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

Sponsor

Centre Hospitalier Metropole Savoie (Other)

Overall Status

Recruiting

CT.gov ID

NCT05833321

Collaborator

(none)

Enrollment

Location

Arm

46.4

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Neoplasms Sarcopenia	Diagnostic Test: Sarcopenia diagnostic test	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

prospective non-randomized interventional studyprospective non-randomized interventional study

Masking:

None (Open Label)

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

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Nov 20, 2022

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Oct 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interventionnal "Hand Grip" Dynamometer Walk test SEFI Nutritional Intake Assessment Questionnaire	Diagnostic Test: Sarcopenia diagnostic test measurement of impedance and physical tests ("hand grip" dynamometer, walking test), SEFI nutritional intake questionnaire

Arm

Intervention/Treatment

Experimental: Interventionnal

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

Diagnostic Test: Sarcopenia diagnostic test

measurement of impedance and physical tests ("hand grip" dynamometer, walking test), SEFI nutritional intake questionnaire

Outcome Measures

Primary Outcome Measures

inclusion period [36 month]
Duration of inclusion period / data collection
Duration of participation of each subject [12 month]
Duration of participation of each subject

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Metropole Savoie	Chambéry	Savoie	France	73011

Sponsors and Collaborators

Centre Hospitalier Metropole Savoie

Investigators

Principal Investigator: fillon aurélie, Centre Hospitalier Metropole Savoie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Metropole Savoie

ClinicalTrials.gov Identifier:

NCT05833321

Other Study ID Numbers:

CHMS22005

First Posted:

Apr 27, 2023

Last Update Posted:

May 2, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endometrial Neoplasms

Ovarian Neoplasms

Sarcopenia

Study Results

No Results Posted as of May 2, 2023