Endocrine Therapy-Induced Alopecia Natural History Evaluation Among Female Breast Cancer Survivors

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Minnesota
Mayo Clinic Health System in Albert Lea
RECRUITING
Albert Lea
Essentia Health Baxter Clinic
RECRUITING
Baxter
Sanford Joe Lueken Cancer Center
RECRUITING
Bemidji
Essentia Health Saint Joseph's Medical Center
RECRUITING
Brainerd
Essentia Health - Deer River Clinic
RECRUITING
Deer River
Essentia Health Saint Mary's - Detroit Lakes Clinic
RECRUITING
Detroit Lakes
Essentia Health Cancer Center
RECRUITING
Duluth
Essentia Health Ely Clinic
RECRUITING
Ely
Essentia Health - Fosston
RECRUITING
Fosston
Fairview Grand Itasca Clinic & Hospital
RECRUITING
Grand Rapids
Essentia Health Hibbing Clinic
RECRUITING
Hibbing
Fairview Range Medical Center
RECRUITING
Hibbing
Essentia Health - International Falls Clinic
RECRUITING
International Falls
Mayo Clinic Health Systems-Mankato
RECRUITING
Mankato
MMCORC CentraCare Monticello Cancer Center
RECRUITING
Monticello
Essentia Health Moose Lake
RECRUITING
Moose Lake
Essentia Health - Park Rapids
RECRUITING
Park Rapids
Fairview Northland Medical Center
RECRUITING
Princeton
Mayo Clinic in Rochester
RECRUITING
Rochester
Essentia Health Sandstone
RECRUITING
Sandstone
Sanford Health Thief River Falls
RECRUITING
Thief River Falls
Essentia Health Virginia Clinic
RECRUITING
Virginia
Sanford Health Worthington
RECRUITING
Worthington
Time Frame
Start Date: 2022-07-06
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 170
Treatments
Observational (alopecia questionnaires and surveys)
Patients complete alopecia questionnaires and surveys and have medical records reviewed on study.
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov