Clinical trial NCT05833321: Prospective Study of Detection of Sarcopenia in Clinical Practice for Patient With Ovarian or Endometrial Cancer
Official title: Prospective Monocentric Study of the Detection of Sarcopenia in Clinical Practice in Patients With Ovarian or Endometrial Cancer Requiring Systemic Oncological Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Neoplasms
Sarcopenia
Lead sponsor: Centre Hospitalier Metropole Savoie
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective non-randomized interventional study
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: clinical screening for sarcopenia
timeFrame: 36 month
measure: Proposal of a composite score for the detection of sarcopenia usable in clinical routine
timeFrame: 36 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chambéry
country: France
facility: Centre Hospitalier Metropole Savoie
state: Savoie
Study officials:
affiliation: Centre Hospitalier Metropole Savoie
name: fillon aurélie
role: PRINCIPAL_INVESTIGATOR
References: