Clinical trial NCT02166281: Impact of Adjuvant Treatment With Aromatase Inhibitor on Sleep Disturbances in Postmenopausal Women With Endocrine Responsive Early Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endocrine Responsive Early Breast Cancer
Keywords: Insomnia
Anxiety
Depression
Restless leg syndrome
Aromatase inhibitor
Body composition
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
Collaborators: name: Ospedale San Raffaele
First posted: 2014-06-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal Women with early stage endocrine responsive breast cancer

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.


Eligibility criteria: 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

Primary outcomes:
measure: The number of participants who suffer from insomnia
timeFrame: 24 months
Secondary outcomes:
measure: The number of participants who suffer from anxiety and depression
timeFrame: 24 months
measure: The number of participants who suffer from Restless
timeFrame: 24 months
measure: Correlating the onset of restless with anxiety, depression and insomnia
timeFrame: 24 months
measure: Describe changes in lean body mass, fat mass, bone mineral density during treatment
timeFrame: 24 months
measure: The number of participants with abnormal level of vitamin d
timeFrame: 24 months
measure: Correlate the changes in body composition with circulating levels of vitamin D
timeFrame: 24 months
measure: Number of fracture and their correlation with the density bone mineral and other parameters of body composition
timeFrame: 24 months
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Azienda Spedali Civili Brescia DH Oncologia
Study officials:
affiliation: Azienda Spedali Civili Brescia
name: Rebecca RP Rebecca, Pedersini
role: PRINCIPAL_INVESTIGATOR
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