Alopecia Secondary to Endocrine Therapy in Postmenopausal Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Alopecia Secondary to Endocrine Therapy in Postmenopausal Women With Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01300871
• Other study ID #: Alopecia
• Secondary ID: 10-0906-CE
• Status: Terminated
• Phase: N/A
• First received: February 18, 2011
• Last updated: September 25, 2014
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: February 2011
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Research Ethics Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of Alopecia Tool (SALT)	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).	1 year	No
Secondary	Comparison of Tamoxifen, AI or Tamoxifen plus AI	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.	1 year	No
Secondary	Severity of Alopecia Tool (SALT)	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.	1 year	No