Prospective Monocentric Study of the Detection of Sarcopenia in Clinical Practice in Patients With Ovarian or Endometrial Cancer Requiring Systemic Oncological Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Proposal of a composite score for the detection of sarcopenia usable in clinical routine
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Proposal of a composite score for the detection of sarcopenia usable in clinical routine
时间窗: 36 month
Statistical analysis of sarcopenia and undernutrition data
clinical screening for sarcopenia
时间窗: 36 month
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.
次要结局
未报告次要终点