Endocrine Therapy-Induced Alopecia Natural History Evaluation Among Female Breast Cancer Survivors
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.
Detailed description
PRIMARY OBJECTIVE: I. To describe the incidence, characteristics, and severity of alopecia related to endocrine therapy in four cohorts of postmenopausal women who have had a diagnosis of breast cancer: patients undergoing endocrine therapy with tamoxifen, patients undergoing endocrine therapy with an aromatase inhibitor, patients undergoing therapy with an aromatase inhibitor in addition to a CDK4/6 inhibitor, and patients not receiving endocrine therapy. A fifth cohort has met the accrual goal and is no longer enrolling: premenopausal women receiving any type of endocrine therapy. SECONDARY OBJECTIVE: I. To investigate the difference in incidence, characteristics, and severity of alopecia between the aforementioned five cohorts of patients. OUTLINE: This is an observational study. Patients complete alopecia questionnaires and surveys and have medical records reviewed on study.
Arms & interventions
- OtherElectronic Health Record Review
Ancillary studies
- OtherQuestionnaire Administration
Complete alopecia questionnaires
- OtherSurvey Administration
Complete alopecia surveys
Outcome measures
Primary
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 years
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 years
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 years
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 years
Eligibility criteria
Study locations (23)
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
Essentia Health Baxter Clinic
Baxter, Minnesota, 56425
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Essentia Health Ely Clinic
Ely, Minnesota, 55731
Essentia Health - Fosston
Fosston, Minnesota, 56542
Fairview Grand Itasca Clinic & Hospital
Grand Rapids, Minnesota, 55744
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Fairview Range Medical Center
Hibbing, Minnesota, 55746
Essentia Health - International Falls Clinic
International Falls, Minnesota, 56649
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001
MMCORC CentraCare Monticello Cancer Center
Monticello, Minnesota, 55362
Essentia Health Moose Lake
Moose Lake, Minnesota, 55767
Essentia Health - Park Rapids
Park Rapids, Minnesota, 56470
Fairview Northland Medical Center
Princeton, Minnesota, 55731
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Sanford Health Thief River Falls
Thief River Falls, Minnesota, 56701
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Sanford Health Worthington
Worthington, Minnesota, 56187