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Alopecia Secondary to Endocrine Therapy in Postmenopausal Women With Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01300871
First received: February 18, 2011
Last updated: April 15, 2011
Last verified: February 2011
History of Changes
  Purpose

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
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Alopecia Secondary to Endocrine Therapy in Postmenopausal Women With Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Severity of Alopecia Tool (SALT) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Comparison of Tamoxifen, AI or Tamoxifen plus AI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: January 2011
Groups/Cohorts
Postmenopausal Women on Endocrine Therapy
Postmenopausal women with Breast Cancer that undergo Endocrine Therapy.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300871

Contacts
Contact: Lindsay Carlsson 416-946-4501 ext 4903 lindsay.carlsson@uhn.on.ca

Locations
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 3M9
Contact: Lindsay Carlsson     416-946-4501 ext 4903     lindsay.carlsson@uhn.on.ca    
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Lindsay Carlsson University Health Network-Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: Lindsay Carlsson, University Health Network-Princess Margaret Hospital
ClinicalTrials.gov Identifier: NCT01300871     History of Changes
Other Study ID Numbers: Alopecia, 10-0906-CE
Study First Received: February 18, 2011
Last Updated: April 15, 2011
Health Authority: Canada: Research Ethics Board

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

ClinicalTrials.gov processed this record on May 23, 2013