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Alopecia Secondary to Endocrine Therapy in Postmenopausal Women With Breast Cancer

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ClinicalTrials.gov Identifier: NCT01300871
Recruitment Status : Terminated (Poor patient accrual)
First Posted : February 23, 2011
Last Update Posted : September 26, 2014
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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
Breast Cancer

Study Type : Observational
Estimated 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 : January 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Group/Cohort
Postmenopausal Women on Endocrine Therapy
Postmenopausal women with Breast Cancer that undergo Endocrine Therapy.



Primary Outcome Measures :
  1. Severity of Alopecia Tool (SALT) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients that attend Medical Oncology Breast Clinics at Princess Margaret Hospital.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300871


Locations
Canada, Ontario
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

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01300871     History of Changes
Other Study ID Numbers: Alopecia
10-0906-CE ( Other Identifier: Research Ethics Board )
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: September 26, 2014
Last Verified: February 2011

Additional relevant MeSH terms:
Breast Neoplasms
Alopecia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hypotrichosis
Hair Diseases
Pathological Conditions, Anatomical