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Alopecia Secondary to Endocrine Therapy in Postmenopausal Women With Breast Cancer

Sponsor
University Health Network, Toronto (Other)
Overall Status
Terminated
CT.gov ID
NCT01300871
Collaborator
(none)
100
Enrollment
1
Location
12
Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study to determine the prevalence and severity of alopecia (hair loss) experienced by postmenopausal breast cancer patients receiving endocrine therapy including Tamoxifen, Letrozole (Femara), Exemestane (Aromasin), or Anastrozole (Arimidex).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Alopecia Secondary to Endocrine Therapy in Postmenopausal Women With Breast Cancer
    Study Start Date :
    Jan 1, 2011
    Actual Study Completion Date :
    Jan 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Postmenopausal Women on Endocrine Therapy

    Postmenopausal women with Breast Cancer that undergo Endocrine Therapy.

    Outcome Measures

    Primary Outcome Measures

    1. Severity of Alopecia Tool (SALT) [1 year]

      The proportion of postmenopausal breast cancer patients on endocrine therapy who experience grade S1 to S5 alopecia as defined by the Severity of Alopecia Tool (SALT).

    Secondary Outcome Measures

    1. Comparison of Tamoxifen, AI or Tamoxifen plus AI [1 year]

      Comparison of the proportion of postmenopausal breast cancer patients treated with Tamoxifen monotherapy, AI monotherapy, or a switch from Tamoxifen to AI who experience alopecia.

    2. Severity of Alopecia Tool (SALT) [1 year]

      To identify the severity, or grade, of hair loss experienced by our target population. The severity of alopecia will be represented as a percentage, again in accordance with the SALT.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Postmenopausal women

    • Diagnosed with hormone-receptor positive breast cancer

    • Commenced adjuvant endocrine therapy ≥ 3 months ago, specifically Tamoxifen, Anastrozole, Exemestane, and/or Letrozole

    • Good command of the English language

    • Under the care of a medical oncologist at Princess Margaret Hospital

    Exclusion Criteria:

    • Previously received chemotherapy

    • Recurrent and/or metastatic disease

    • History of endocrine, dermatology, or immune system disorders known to alter hair growth (ie. Hypothyroidism and iron deficiency)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Princess Margaret Hospital Toronto Ontario Canada M5G 3M9

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    • Principal Investigator: Lindsay Carlsson, University Health Network-Princess Margaret Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT01300871
    Other Study ID Numbers:
    • Alopecia
    • 10-0906-CE
    First Posted:
    Feb 23, 2011
    Last Update Posted:
    Sep 26, 2014
    Last Verified:
    Feb 1, 2011
    Additional relevant MeSH terms:
    Breast Neoplasms
    Alopecia

    Study Results

    No Results Posted as of Sep 26, 2014