Assessment of the Prevalence of Sarcopenia by CT Scan in Patients Diagnosed With Head & Neck Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Assessment of the prevalence of sarcopenia by cervical CT scan (C3)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Assessment of the prevalence of sarcopenia by cervical CT scan (C3)
时间窗: 6 months
Number of patients with sarcopenia at diagnosis and during treatments
次要结局
- Assessment of hypoalbuminemia(6 month)
- De- and undernutrition(6 month)
- Assessment of hospitalizations treatment-related complications(6 months)
- Compliance to the treatment(6 months)
- complete response rate(6 months)