Assessment of the Prevalence of Sarcopenia by CT Scan in Patients Diagnosed With Head & Neck Cancer (SARVADS 1)
Assessment of the Prevalence of Sarcopenia by CT Scan in Patients Diagnosed With Head & Neck Carcinoma
Sarcopenia is defined by the reduction in skeletal muscle mass and physical performance. It results in a decrease in muscle strength, overall physical activity, walking and the development of balance disorders and falls. It is one of the natural consequences of aging and contributes to frailty and the appearance of geriatric syndrome (s) (Chandapasirt et al, 2015; Cruz-Jentoft et al, 2010).
Its prevalence in patients with Head & Neck cancer is 39% (Hua et al, 2020) and is associated with an increase in postoperative complications (Achim et al, 2017; Bril et al, 2019), with greater toxicity of chemotherapy. (Wendrich et al, 2017) and reduced overall survival (Hua et al, 2020).
It is measured by CT scan (assessment of muscle volume with respect to L3 using IMAGE J software) (Teigen et al, 2018) and by clinical tests (performance tests) (Swartz et al, 2016, Cruz-Jentoft et al, 2010).
Several studies have shown a possible assessment of sarcopenia by measuring skeletal muscle mass with regard to C3 (Ufuk et al, 2019; Swartz et al, 2016).
This trial aims to evaluate the prevalence of sarcopenia in head and neck cancer evaluated by CT at C3.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：Magali BALAVOINE
- 电话号码：0033 241682940
- 邮箱：m.balavoine@weprom.fr
研究联系人备份
- 姓名：Jonas DUBU
- 邮箱：jonas.dubu@i-l-c.fr
学习地点
-
-
-
Le Mans、法国、72000
- 招聘中
- Clinique Victor Hugo / Centre Jean Bernard
-
接触：
- Jonas DUBU
- 电话号码：+33 769510938
- 邮箱：jonas.dubu@i-l-c.fr
-
首席研究员：
- Katell LE DU, MD
-
首席研究员：
- Amandine RUFFIER, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- patient over 18 years old,
- affiliated to the social security scheme,
- suffering from locally advanced head & neck cancer (stages I to IVB) at diagnosis,
- not operable,
- justifying treatment by radiotherapy, whether or not associated with chemotherapy or targeted therapy (eg: monoclonal antibodies, immunotherapy) whatever the proposed modalities.
Exclusion Criteria:
- patient treated by non-conservative surgery and cervical lymph node dissection making it impossible to assess muscle mass with regard to C3,
- metastatic disease,
- minor patient,
- adult patient under guardianship,
- pregnancy or breastfeeding in progress.
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
study population
Patient diagnosed with head & neck carcinoma at diagnosis
|
evaluation of sarcopenia by CT san at the C3 vertebrae
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Assessment of the prevalence of sarcopenia by cervical CT scan (C3)
大体时间：6 months
|
Number of patients with sarcopenia at diagnosis and during treatments
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Assessment of hypoalbuminemia
大体时间：6 month
|
Number of patients presenting an hypoalbuminemia.
|
6 month
|
|
De- and undernutrition
大体时间：6 month
|
Number of patients with a BMI <18 and with a prescription for nutritional complements.
|
6 month
|
|
Compliance to the treatment
大体时间：6 months
|
Number of patients having the complete planned treatment
|
6 months
|
|
complete response rate
大体时间：6 months
|
Number of patients with a complete response on the end-of-treatment evaluation scanner according to the RECIST or PERCIST criteria in the numerator out of the total number of patients in the denominator
|
6 months
|
|
Assessment of hospitalizations treatment-related complications
大体时间：6 months
|
Number of hospitalizations per patient for treatment-related complications
|
6 months
|
合作者和调查者
赞助
调查人员
- 研究主任：LE DU Katell, MD、Weprom
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.