Endocrine Therapy-Induced Alopecia in Postmenopausal and Premenopausal Female Breast Cancer Patients
ConditionBreast Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMayo Clinic
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Postmenopausal and premenopausal women with a diagnosis of breast cancer.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Electronic Health Record Review
Other interventionAncillary studies
Questionnaire Administration
Other interventionComplete alopecia questionnaires
Survey Administration
Other interventionComplete alopecia surveys
Treatment groups
170 Participants
are divided into 1 treatment groupGroup A: Observational (alopecia questionnaires and surveys)3 interventions
Trial outcomes
Primary outcomes
1
Estimation and characterization of patient-reported treatment-emergent alopecia within and across the cohorts
Exact 95% confidence intervals will be created within each cohort and compared graphically using forest plots. Plots of alopecia incidence rates and severity will be plotted over time by cohort.
Time frame
Up to study completion; up to two years2
Overall impact on patient's quality of life
Descriptive summaries of all the questions on the baseline and follow-up questionnaires will be tabulated to facilitate our understanding of patient-experienced alopecia and to provide a comprehensive picture of how alopecia is treated, as well as to quantify the overall impact on patient's quality of life. Standardized differences will be computed in order to give a common metric for all variables. The largest standardized difference between the pairwise cohorts will be reported.
Time frame
Up to study completion; up to two years3
Incidence rate of treatment-emergent alopecia
A cumulative incidence function will be estimated in order to calculate the cumulative incidence rate (i.e. time to initial onset) of treatment-emergent alopecia, treating death and disease progression as competing risks for each cohort. Cox proportional hazards models will be used to compare differences between treatment-emergent alopecia risk between the control cohort (n=20) and the combined treatment cohorts (n = 80). The covariates included in the regression model will include age (years) and alopecia scores at baseline.
Time frame
Up to study completion; up to two years4
Risk of treatment-emergent alopecia
A longitudinal analysis will be used for the binary response of whether the patient experiences treatment-emergent alopecia; this mixed model will contain an interaction between control versus treatment cohort and time, both as categorical variables, and a random intercept and slope by patient. The above covariates will also be adjusted for and piecewise splices will be used to account for any nonlinearity. The goal of the longitudinal analysis is to explore whether the risk of treatment-emergent alopecia increases with endocrine therapy exposure over time and whether this risk differs between cohorts.
Time frame
Up to study completion; up to two yearsSponsors and contacts
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Source ClinicalTrials.gov