Trial Title:
Endocrine Therapy-Induced Alopecia in Postmenopausal and Premenopausal Female Breast Cancer Patients
NCT ID:
NCT05612100
Condition:
Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Alopecia
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Observational (alopecia questionnaires and surveys)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Complete alopecia questionnaires
Arm group label:
Observational (alopecia questionnaires and surveys)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Complete alopecia surveys
Arm group label:
Observational (alopecia questionnaires and surveys)
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 of patients will also be included, consisting of
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.
Criteria for eligibility:
Study pop:
Postmenopausal and premenopausal women with a diagnosis of breast cancer.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic Health System in Albert Lea
Address:
City:
Albert Lea
Zip:
56007
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Mina Hanna, M.D.
Email:
Principal Investigator
Facility:
Name:
Essentia Health Baxter Clinic
Address:
City:
Baxter
Zip:
56425
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Bret E. Friday, M.D.
Email:
Principal Investigator
Facility:
Name:
Sanford Joe Lueken Cancer Center
Address:
City:
Bemidji
Zip:
56601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jarrett Failing, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Jarrett Failing, M.D.
Email:
Principal Investigator
Facility:
Name:
Essentia Health Saint Joseph's Medical Center
Address:
City:
Brainerd
Zip:
56401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Bret E. Friday, M.D.
Email:
Principal Investigator
Facility:
Name:
Essentia Health - Deer River Clinic
Address:
City:
Deer River
Zip:
56636
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Bret E. Friday, M.D.
Email:
Principal Investigator
Facility:
Name:
Essentia Health Saint Mary's - Detroit Lakes Clinic
Address:
City:
Detroit Lakes
Zip:
56501
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Bret E. Friday, M.D.
Email:
Principal Investigator
Facility:
Name:
Essentia Health Cancer Center
Address:
City:
Duluth
Zip:
55805
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Bret E. Friday, M.D.
Email:
Principal Investigator
Facility:
Name:
Essentia Health Ely Clinic
Address:
City:
Ely
Zip:
55731
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Bret E. Friday, M.D.
Email:
Principal Investigator
Facility:
Name:
Essentia Health - Fosston
Address:
City:
Fosston
Zip:
56542
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Bret E. Friday, M.D.
Email:
Principal Investigator
Facility:
Name:
Fairview Grand Itasca Clinic & Hospital
Address:
City:
Grand Rapids
Zip:
55744
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anastas Provatas, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Anastas Provatas, M.D.
Email:
Principal Investigator
Facility:
Name:
Essentia Health Hibbing Clinic
Address:
City:
Hibbing
Zip:
55746
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Bret E. Friday, M.D.
Email:
Principal Investigator
Facility:
Name:
Fairview Range Medical Center
Address:
City:
Hibbing
Zip:
55746
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anastas Provatas, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Anastas Provatas, M.D.
Email:
Principal Investigator
Facility:
Name:
Essentia Health - International Falls Clinic
Address:
City:
International Falls
Zip:
56649
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Bret E. Friday, M.D.
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic Health Systems-Mankato
Address:
City:
Mankato
Zip:
56001
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Stephan D. Thome, M.D.
Email:
Principal Investigator
Facility:
Name:
MMCORC CentraCare Monticello Cancer Center
Address:
City:
Monticello
Zip:
55362
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yan Ji, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Yan Ji, M.D.
Email:
Principal Investigator
Facility:
Name:
Essentia Health Moose Lake
Address:
City:
Moose Lake
Zip:
55767
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Bret E. Friday, M.D.
Email:
Principal Investigator
Facility:
Name:
Essentia Health - Park Rapids
Address:
City:
Park Rapids
Zip:
56470
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Bret E. Friday, M.D.
Email:
Principal Investigator
Facility:
Name:
Fairview Northland Medical Center
Address:
City:
Princeton
Zip:
55731
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anastas Provatas, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Anastas Provatas, M.D.
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Elizabeth Cathcart-Rake, M.D.
Email:
Principal Investigator
Facility:
Name:
Essentia Health Sandstone
Address:
City:
Sandstone
Zip:
55072
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Bret E. Friday, M.D.
Email:
Principal Investigator
Facility:
Name:
Sanford Health Thief River Falls
Address:
City:
Thief River Falls
Zip:
56701
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amit Panwalkar, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Amit Panwalkar, M.D.
Email:
Principal Investigator
Facility:
Name:
Essentia Health Virginia Clinic
Address:
City:
Virginia
Zip:
55792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Bret E. Friday, M.D.
Email:
Principal Investigator
Facility:
Name:
Sanford Health Worthington
Address:
City:
Worthington
Zip:
56187
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jonathan Bleeker, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Investigator:
Last name:
Jonathan Bleeker, M.D.
Email:
Principal Investigator
Start date:
July 6, 2022
Completion date:
August 1, 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05612100
https://www.mayo.edu/research/clinical-trials
