NCT01300871

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

September 26, 2014

Status Verified

February 1, 2011

First QC Date

February 18, 2011

Last Update Submit

September 25, 2014

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Comparison of Tamoxifen, AI or Tamoxifen plus AI

    1 year

  • Severity of Alopecia Tool (SALT)

    1 year

Study Arms (1)

Postmenopausal Women on Endocrine Therapy

Postmenopausal women with Breast Cancer that undergo Endocrine Therapy.

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 3M9, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lindsay Carlsson

    University Health Network-Princess Margaret Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 23, 2011

Study Start

January 1, 2011

Study Completion

January 1, 2012

Last Updated

September 26, 2014

Record last verified: 2011-02

Locations

CA(1)