Natural History Evaluation Among Female Breast Cancer Survivors with Endocrine Therapy-Induced Alopecia
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 22-004341
- Albert Lea, Minnesota: 22-004341
- Mankato, Minnesota: 22-004341
NCT ID: NCT05612100
Sponsor Protocol Number: MC220902
About this study
The purpose of this study is to learn about potential side effects facing people who are undergoing treatments for their cancer, specifically, hair loss. While this is not a well-documented side effect of hormone-blocking medications (such as tamoxifen, letrozole, anastrozole, or exemestane), we have preliminary evidence that it is a problem for some patients getting this treatment. This study will include some patients receiving the hormone therapy and some patients who are not, so we can better understand whether patients getting the hormonal therapy have more hair loss than patients who are not getting such.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Registration - 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 written informed consent.
- Ability to complete questionnaire(s) by themselves or with assistance.
- Filling into one of the 5 groups discussed in section 5.0 (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).
Registration - 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.
Eligibility last updated 7/18/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Elizabeth Cathcart-Rake, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Albert Lea, Minn.
Mayo Clinic principal investigator Mina Hanna, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Mankato, Minn.
Mayo Clinic principal investigator Stephan Thome, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available