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

Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Other)
Overall Status
Unknown status
CT.gov ID
NCT02166281
Collaborator
Ospedale San Raffaele (Other)
200
Enrollment
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Study Start Date :
    May 1, 2014
    Anticipated Primary Completion Date :
    May 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. The number of participants who suffer from insomnia [24 months]

      We use some validated questionnaires to measure this item

    Secondary Outcome Measures

    1. The number of participants who suffer from anxiety and depression [24 months]

      We use some validated questionnaires to measure this item

    2. The number of participants who suffer from Restless [24 months]

      We use some validated questionnaires to measure this item

    3. Correlating the onset of restless with anxiety, depression and insomnia [24 months]

      We analyse correlation into the database

    4. Describe changes in lean body mass, fat mass, bone mineral density during treatment [24 months]

      We analyse this items after DEXA

    5. The number of participants with abnormal level of vitamin d [24 months]

      We asses participants with levels of vitamin out of range

    6. Correlate the changes in body composition with circulating levels of vitamin D [24 months]

      We use statistic software to asses changes

    7. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Azienda Spedali Civili Brescia DH Oncologia Brescia Italy 25123

    Sponsors and Collaborators

    • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
    • Ospedale San Raffaele

    Investigators

    • Principal Investigator: Rebecca RP Rebecca, Pedersini, Azienda Spedali Civili Brescia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Study coordinators, Dr Rebecca Pedersini, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
    ClinicalTrials.gov Identifier:
    NCT02166281
    Other Study ID Numbers:
    • Comfort
    First Posted:
    Jun 18, 2014
    Last Update Posted:
    Jun 18, 2014
    Last Verified:
    Jun 1, 2014
    Keywords provided by Study coordinators, Dr Rebecca Pedersini, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
    Insomnia
    Anxiety
    Depression
    Restless leg syndrome
    Aromatase inhibitor
    Body composition
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jun 18, 2014