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Trial Title:
Prospective Study of Detection of Sarcopenia in Clinical Practice for Patient With Ovarian or Endometrial Cancer
NCT ID:
NCT05833321
Condition:
Ovarian Neoplasms
Sarcopenia
Conditions: Official terms:
Endometrial Neoplasms
Ovarian Neoplasms
Sarcopenia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
prospective non-randomized interventional study
Primary purpose:
Diagnostic
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
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Sarcopenia diagnostic test
Description:
measurement of impedance and physical tests ("hand grip" dynamometer, walking test), SEFI
nutritional intake questionnaire
Arm group label:
Interventionnal
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
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier Metropole Savoie
Address:
City:
Chambéry
Zip:
73011
Country:
France
Status:
Recruiting
Contact:
Last name:
jego florence, ARC
Phone:
0479965813
Investigator:
Last name:
fillon aurélie
Email:
Principal Investigator
Investigator:
Last name:
marques nathalie
Email:
Sub-Investigator
Start date:
November 20, 2022
Completion date:
October 2026
Lead sponsor:
Agency:
Centre Hospitalier Metropole Savoie
Agency class:
Other
Source:
Centre Hospitalier Metropole Savoie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05833321
