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

RECRUITINGSponsored by Mayo Clinic
Actively Recruiting
SponsorMayo Clinic
Started2022-07-06
Est. completion2028-06-30
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations23 sites

Summary

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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

* Age \>= 18 years
* 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)
* Provide informed consent
* Ability to complete questionnaire(s) by themselves or with assistance
* Filling into one of the 5 groups (understanding that groups will close once they complete their accrual goals of 30 patients)
* Willingness to complete questionnaires every 3 months
* Ability to complete the first questionnaire within 2 weeks of therapy initiation (for the four arms that are receiving adjuvant hormonal therapy)

  * For patients starting tamoxifen or an aromatase inhibitor: within 2 weeks of starting tamoxifen or aromatase inhibitor
  * 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).

Exclusion Criteria:

* 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
* 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)
* Prior use of endocrine therapy for breast cancer
* Receipt of chemotherapy over the previous 6 months

Conditions3

Breast CancerBreast CarcinomaCancer

Locations23 sites

Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
Clinical Trials Referral Office855-776-0015mayocliniccancerstudies@mayo.edu
Essentia Health Baxter Clinic
Baxter, Minnesota, 56425
Bret E. Friday, M.D.612-624-2620ccinfo@umn.edu
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Jarrett Failing, M.D.612-624-2620ccinfo@umn.edu
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Bret E. Friday, M.D.612-624-2620ccinfo@umn.edu
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Bret E. Friday, M.D.612-624-2620ccinfo@umn.edu

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