Alopecia Secondary to Endocrine Therapy in Postmenopausal Women With Breast Cancer

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).

Study Overview

• Status: Terminated
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 3M9
      • Princess Margaret Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients that attend Medical Oncology Breast Clinics at Princess Margaret Hospital.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion: December 7, 2022
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: February 18, 2011
• First Submitted That Met QC Criteria: February 22, 2011
• First Posted (Estimate): February 23, 2011

Study Record Updates

• Last Update Posted (Estimate): September 26, 2014
• Last Update Submitted That Met QC Criteria: September 25, 2014
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Breast Neoplasms; Alopecia
• Other Study ID Numbers: Alopecia; 10-0906-CE (Other Identifier: Research Ethics Board)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No