RECRUITING

Endocrine Therapy-Induced Alopecia in Postmenopausal and Premenopausal Female Breast Cancer Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study evaluates endocrine therapy-induced alopecia among postmenopausal and premenopausal female patients with breast cancer. Alopecia is one of the most feared side effects of cancer-directed therapy, causing distress in women starting treatment for breast cancer. While alopecia is a well-known side effect of many chemotherapy drugs, it has also been reported by women undergoing endocrine therapy. Despite the frequent reports of alopecia related to endocrine therapy, hair loss is rarely reported as a side effect of endocrine therapy and the exact characterization of alopecia is not well understood. By having postmenopausal and premenopausal breast cancer patients describe their hair loss symptoms experienced while undergoing endocrine therapy, researchers may be able to better characterize the incidence, timing, duration, and severity of alopecia and whether the different types of endocrine therapy cause more or less trouble in this regard.

Official Title

Endocrine Therapy-Induced Alopecia Natural History Evaluation Among Female Breast Cancer Survivors

Quick Facts

Study Start:2022-07-06
Study Completion:2025-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05612100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>= 18 years
  2. * Women with a diagnosis of breast cancer who are being treated with curative intent, with the one exception being women who are receiving CDK4/6 inhibitors (these patients being allowed to have more advanced disease)
  3. * Provide informed consent
  4. * Ability to complete questionnaire(s) by themselves or with assistance
  5. * Filling into one of the 5 groups (understanding that groups will close once they complete their accrual goals of 30 patients)
  6. * Willingness to complete questionnaires every 3 months
  7. * Ability to complete the first questionnaire within 2 weeks of therapy initiation (for the four arms that are receiving adjuvant hormonal therapy)
  8. * For patients starting tamoxifen or an aromatase inhibitor: within 2 weeks of starting tamoxifen or aromatase inhibitor
  9. * For patients starting a CDK 4/6 inhibitor: within 2 weeks of starting the CDK 4/6 inhibitor (patients may have started an aromatase inhibitor at any time prior to initiation of CDK 4/6 inhibitor).
  1. * Verbal baseline alopecia \>= 2 on an 11 point scale (from none = 0 to severe = 10). The question to use for this item is: Please rate your hair thinning or loss on a scale from 0 to 10, with 0 being no hair loss and 10 being complete hair loss
  2. * Planned receipt of chemotherapy or another cancer-directed therapy concurrently (e.g., everolimus, etc.; note that a CDK4/6 inhibitor is allowed within cohort 3)
  3. * Prior use of endocrine therapy for breast cancer
  4. * Receipt of chemotherapy over the previous 6 months

Contacts and Locations

Principal Investigator

Elizabeth Cathcart-Rake, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
United States
Essentia Health Baxter Clinic
Baxter, Minnesota, 56425
United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
United States
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805
United States
Essentia Health Ely Clinic
Ely, Minnesota, 55731
United States
Essentia Health - Fosston
Fosston, Minnesota, 56542
United States
Fairview Grand Itasca Clinic & Hospital
Grand Rapids, Minnesota, 55744
United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
United States
Fairview Range Medical Center
Hibbing, Minnesota, 55746
United States
Essentia Health - International Falls Clinic
International Falls, Minnesota, 56649
United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001
United States
MMCORC CentraCare Monticello Cancer Center
Monticello, Minnesota, 55362
United States
Essentia Health Moose Lake
Moose Lake, Minnesota, 55767
United States
Essentia Health - Park Rapids
Park Rapids, Minnesota, 56470
United States
Fairview Northland Medical Center
Princeton, Minnesota, 55731
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
Essentia Health Sandstone
Sandstone, Minnesota, 55072
United States
Sanford Health Thief River Falls
Thief River Falls, Minnesota, 56701
United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
United States
Sanford Health Worthington
Worthington, Minnesota, 56187
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Elizabeth Cathcart-Rake, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-06
Study Completion Date2025-08-01

Study Record Updates

Study Start Date2022-07-06
Study Completion Date2025-08-01

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Carcinoma