NCT02166281

Impact of Adjuvant Treatment With Aromatase Inhibitor on Sleep Disturbances in Postmenopausal Women With Endocrine Responsive Early Breast Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endocrine Responsive Early Breast Cancer

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-05-01
• First posted: 2014-06-18
• Last updated: 2014-06-18

Locations

1 site across 1 country: Italy