Characterization of Neuromuscular Function and Fatigue After Breast Cancer Treated With Adjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Maximal isometric muscle strength for knee extensors
研究概览
简要总结
This is a transversal monocentric study comparing two groups of women (group 1, patient group : patients who have been treated for a breast cancer with taxane-based chemotherapy ; group 2, control group : healthy volunteers). The aim of this study is to evaluate if a difference exists regarding the maximal isometric muscle strength between group 1 and 2.
详细描述
All subjects will be evaluated a single time during two hours. For patients from group 1 the evaluation should take place within the two weeks that follow the end of adjuvant treatment. There is no specificity regarding evaluation of volunteers from group 2, their evaluation can take place at any time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Group 1 - Patients :
- •Give written inform consent
- •Age ≥ 18 years
- •Affiliate to social security system
- •Ability to speak, understand and read French
- •Breast cancer, Stage II or III, treated by taxane-based chemotherapy
- •Group 2 - Control group :
- •Give written inform consent
- •Age ≥ 18 years
- •Affiliate to social security system
- •Ability to speak, understand and read French
排除标准
- •Group 1 - Patients :
- •< 18 years old or patients ≥ 18 years old under guardianship, or supervision
- •Psychiatric, musculoskeletal or neurologic disorders
- •Patients presenting one of the following contraindications to transcranial magnetic stimulation :
- •Presence of a implanted metallic foreign-body (cochlear implant, drug pump system, pacemaker, etc.)
- •History of epilepsy
- •Brain injury (vascular, traumatic, tumour-induced, infectious or metabolic)
- •Women that are pregnant
- •Serious or recent heart disease
- •Group 2 -Control group :
- •< 18 years old or patients ≥ 18 years old under guardianship, or supervision
- •Psychiatric, musculoskeletal or neurologic disorders
- •Pacemaker implantation
- •History of cancer
- •All known chronic disease
- •Subjects presenting one of the following contraindications to transcranial magnetic stimulation :
- •Presence of a implanted metallic foreign-body (cochlear implant, drug pump system, pacemaker, etc.)
- •History of epilepsy
- •Brain injury (vascular, traumatic, tumour-induced, infectious or metabolic)
- •Women that are pregnant
- •Serious or recent heart disease
结局指标
主要结局
Maximal isometric muscle strength for knee extensors
时间窗: At Inclusion
Measured with force sensors. Significant differences between the two groups will be assessed
次要结局
- Number of Participants with neuromuscular fatigue(At Inclusion)
- Number of Participants with muscle architecture.(At Inclusion)
- Number of Participants with body composition.(At Inclusion)
- Number of Participants with subjective fatigue.(At Inclusion)