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NCT05612100
Evaluation of Endocrine Therapy-Induced Alopecia Among Postmenopausal and Premenopausal Female Patients With Breast Cancer
Conditions: Breast Carcinoma
Sex: Female
Ages: 18 Years – N/A
Enrollment: 150
Sponsor: Mayo Clinic
Location: United States
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 Criteria
Inclusion Criteria:Age >= 18 yearsWomen 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 consentAbility to complete questionnaire(s) by themselves or with assistanceFilling 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 monthsAbility to complete the first questionnaire within 2 weeks of therapy initiation (for the four arms that are receiving adjuvant hormonal therapy)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 lossPlanned 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 cancerReceipt of chemotherapy over the previous 6 months
Source: ClinicalTrials.gov (NCT05612100). StuddyBuddy aggregates publicly available trial information.