Impact of Adjuvant Treatment With Aromatase Inhibitor on Sleep Disturbances in Postmenopausal Women With Endocrine Responsive Early Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The number of participants who suffer from insomnia
研究概览
简要总结
Insomnia is common in Breast cancer patients during adjuvant therapy with aromatase inhibitor.
However it is difficult to establish whether it is due to the knowledge of the disease or the treatment administred.
The investigators designed a cohort study in which questionnaires for the assessment of sleep quality (Pittsburgh Sleep Quality Index and Insomnia Severity Index), anxiety (State and Trait Anxiety Inventory), depression (Beck Depression Inventory), for the quality of life in general (Functional Assessment of Cancer Therapy) and for the evaluation of RLS (Restless Legs Syndrome Rating Scale) will be prospectively administered to patients with early breast cancer at baseline and during adjuvant treatment with aromatase inhibitors.
As secondary aims the investigators will also evaluate dietary and lifes' factors, born turn over and BMI.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Women with a histological diagnosis of invasive operated breast cancer (any pT, any pN)
- •Women with more than 60 years
- •Women less than 60 years with amenorrhea for at least 12 months and FSH and estradiol values in the range of menopause
- •Signature of written informed consent.
排除标准
- •Locally advanced or metastatic disease (M1)
- •A history of breast cancer or other cancers diagnosed in the last 10 years, to exception of basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- •History of severe osteoporosis before the diagnosis of breast cancer
- •Bisphosphonate therapy before the diagnosis of breast cancer
- •Other serious medical conditions that could limit the ability of the patient to participate in the study
结局指标
主要结局
The number of participants who suffer from insomnia
时间窗: 24 months
We use some validated questionnaires to measure this item
次要结局
- Describe changes in lean body mass, fat mass, bone mineral density during treatment(24 months)
- The number of participants with abnormal level of vitamin d(24 months)
- The number of participants who suffer from anxiety and depression(24 months)
- The number of participants who suffer from Restless(24 months)
- Correlating the onset of restless with anxiety, depression and insomnia(24 months)
- Correlate the changes in body composition with circulating levels of vitamin D(24 months)
- Number of fracture and their correlation with the density bone mineral and other parameters of body composition(24 months)
研究者
Study coordinators
Dr Rebecca Pedersini
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia