Alopecia Secondary to Endocrine Therapy in Postmenopausal Women With Breast Cancer

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01300871

Enrollment

100

Registered

2011-02-23

Start date

2011-01-31

Completion date

2012-01-31

Last updated

2014-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

40 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Countries

Canada

Outcome results