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

• Conditions: Endocrine Responsive Early Breast Cancer

• Registration Number: NCT02166281
• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-20
• Status Verified: 2014-06
• Study First Submitted QC: 2014-06-16
• Last Update Submitted: 2014-06-16
• Study First Posted: 2014-06-18
• Last Update Posted: 2014-06-18
• Primary Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of participants who suffer from insomnia	24 months	We use some validated questionnaires to measure this item

Secondary Outcome Measures

Name	Time	Method
The number of participants who suffer from anxiety and depression	24 months	We use some validated questionnaires to measure this item
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 with abnormal level of vitamin d	24 months	We asses participants with levels of vitamin out of range
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

Trial Locations

Locations (1)

Azienda Spedali Civili Brescia DH Oncologia; 🇮🇹 Brescia, Italy