Endocrine Therapy for Hair Loss in Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates hair loss (alopecia) caused by endocrine therapy in women with breast cancer. Researchers aim to determine the frequency and severity of this hair loss and whether different endocrine treatments affect this side effect differently. Women with breast cancer who are beginning endocrine therapy, such as tamoxifen or aromatase inhibitors, may qualify. Participants will complete questionnaires about their hair loss experience every three months. This information will enhance understanding and management of this side effect for future patients. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications. However, you cannot participate if you are planning to receive chemotherapy or other cancer-directed therapies at the same time, except for certain allowed medications like CDK4/6 inhibitors.
What is the safety track record for endocrine therapy?
Research has shown that treatments for breast cancer, such as endocrine therapy, can lead to hair loss. This hair loss, known as alopecia, often links to common medications like aromatase inhibitors and tamoxifen. One study found that most patients experienced only mild hair thinning, classified as grade 1. About 43–58% of patients noticed hair loss within a year of starting treatment.
These findings indicate that hair loss is a common side effect, but it is usually not severe. However, patients should be aware that this might occur.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it seeks to better understand endocrine therapy-induced alopecia in female breast cancer patients, a side effect that can significantly impact quality of life. Unlike typical approaches focusing on treating hair loss after it occurs, this observational study aims to gather detailed patient experiences and medical records to uncover patterns and potential predictive factors. This data-driven approach could lead to more personalized treatment plans, helping to prevent or mitigate hair loss for patients undergoing endocrine therapy in the future.
What evidence suggests that endocrine therapy might be an effective treatment for hair loss in breast cancer?
Research has shown that hair loss can be a noticeable side effect of hormone therapy used in breast cancer treatment. In one study, 67% of patients taking aromatase inhibitors and 33% taking tamoxifen experienced some hair loss. Most cases were mild, with 92% of patients reporting only the least severe level of hair loss. Another study found that 18% of patients on hormone therapy alone felt moderate to extreme concern about their hair loss. Overall, hair loss from hormone therapy is less common than with chemotherapy, but it still affects many patients. Participants in this trial will complete alopecia questionnaires and surveys to further understand the impact of endocrine therapy on hair loss.13678
Who Is on the Research Team?
Elizabeth Cathcart-Rake, M.D.
Principal Investigator
Mayo Clinic in Rochester
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observational
Participants complete alopecia questionnaires and surveys and have medical records reviewed
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Endocrine Therapy
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients complete alopecia questionnaires and surveys and have medical records reviewed on study.
Endocrine Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
- Breast cancer
- Prostate cancer
- Endometrial cancer
- Ovarian cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Endocrine Therapy–Induced Alopecia in Patients With ...
Alopecia was attributed to aromatase inhibitors in 75 patients (67%) and tamoxifen in 37 (33%). Severity was grade 1 in 96 of 104 patients (92%) ...
Perceptions of Delayed Alopecia Among Breast Cancer ...
Moderate to extreme bother from hair loss was reported by 27% of chemotherapy recipients, by 18% of endocrine therapy only recipients, and by 14% of patients ...
Endocrine Therapy-Induced Alopecia in Postmenopausal ...
This study evaluates endocrine therapy-induced alopecia among postmenopausal and premenopausal female patients with breast cancer. Alopecia is one of the ...
Natural History Evaluation Among Female Breast Cancer ...
Natural History Evaluation Among Female Breast Cancer Survivors with Endocrine Therapy-Induced Alopecia.
Endocrine Therapy–Induced Alopecia in Patients With ...
5 An alopecia meta-analysis of 13 415 patients in 35 clinical trials revealed an overall incidence of alopecia of 4.4%, with the highest ...
Hair regrowth in endocrine therapy alopecia with ...
There is a great need to find safe and effective treatments for endocrine therapy alopecia in women undergoing estrogen-inhibiting therapies for breast cancer.
Hair loss: alopecia fears and realities for survivors of breast ...
Within 12 months of the initiation of an endocrine therapy, 43–58% of patients reported noticing significant alopecia (6,8). A striking 8.3% of patients ...
Cancer-Related Alopecia Risk and Treatment
Endocrine therapy-induced alopecia (EIA) is a recognized side effect of hormone-targeting treatments used to treat breast, prostate, ovarian, ...
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