Endocrine Responsive Early Breast Cancer
Conditions
Keywords
Insomnia, Anxiety, Depression, Restless leg syndrome, Aromatase inhibitor, Body composition
Brief summary
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.
Interventions
None listed
Sponsors
Ospedale San Raffaele
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of participants who suffer from insomnia | 24 months | We use some validated questionnaires to measure this item |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of participants who suffer from Restless | 24 months | We use some validated questionnaires to measure this item |
| Correlating the onset of restless with anxiety, depression and insomnia | 24 months | We analyse correlation into the database |
| Describe changes in lean body mass, fat mass, bone mineral density during treatment | 24 months | We analyse this items after DEXA |
| The number of participants who suffer from anxiety and depression | 24 months | We use some validated questionnaires to measure this item |
| Correlate the changes in body composition with circulating levels of vitamin D | 24 months | We use statistic software to asses changes |
| Number of fracture and their correlation with the density bone mineral and other parameters of body composition | 24 months | We use statistic software to asses correlation |
| The number of participants with abnormal level of vitamin d | 24 months | We asses participants with levels of vitamin out of range |
Countries
Italy
Contacts
Primary ContactRebecca RP Pedersini, Principal Investigator
Outcome results
None listed