NCT01332916终止2 期
Impact of Cancer on Memory Functioning: Understanding Disorders Using Approaches in Neuropsychology and Neuroimaging
Centre Francois Baclesse4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Assess the relationship between memory impairment and brain dysfunction
研究概览
简要总结
The purpose of this study is to investigate memory problems in patients with cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •for patients:
- •Patients aged 45 and over
- •Patients from Grade 3 'end of primary schooling "minimum (scale Barbizet)
- •Non-Metastatic Breast Cancer
- •Adjuvant Chemotherapy: FEC, including Docetaxel Protocols
- •No major cognitive impairment
- •No previous neurological
- •Lack of personality disorders and psychiatric disorders evolutionary
- •Having signed the informed consent of study participation
- •Inclusion Criteria for control group:
- •Women from the general population aged 45 and over, and matched in age and cultural level in patients
- •Topics of Grade 3 'end of primary schooling "minimum (scale Barbizet)
- •No prior cancer
- •No major cognitive impairment
- •No previous neurological
- •Lack of personality disorders and psychiatric disorders evolutionary
- •Participating in the IMAP Protocol No. ID-BCR: 2007-A00414-49 or IMAP+(n° ID RCB 2011-A01493-38)(see how the study below) have signed forms no objection and consent to study participation
排除标准
- •Traduction (français > anglais)
- •Metastatic
- •Cancer of the breast other than primitive
- •Patients with paraneoplastic syndrome
- •Patients under 45 years
- •Patients whose achievement is below level 3 'end of primary schooling "(scale Barbizet)
- •Patients with adjuvant chemotherapy is associated with targeted therapy
- •Patients who have received other cancer treatments (chemotherapy or radiotherapy brain)
- •Contraindication to the implementation of an MRI (claustrophobia, metal objects in the body)
- •disorders of higher functions existing in the administration of chemotherapy
- •Neurologic earlier
- •Pathology psychiatric evolutionary
- •Refusal of participation
- •Patients unable to meet the cognitive tests
- •Heavy drinking
结局指标
主要结局
Assess the relationship between memory impairment and brain dysfunction
时间窗: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy
The main objective is to assess the relationship between memory impairment and brain dysfunction in patients treated with adjuvant chemotherapy for breast cancer (before and after treatment), compared to a group of healthy subjects.
次要结局
- Impact of age(Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy)
研究者
研究点 (4)
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