Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Cancer
NCT ID: NCT05417308
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
50 participants
INTERVENTIONAL
2023-03-01
2025-12-31
Brief Summary
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Detailed Description
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I. To evaluate the safety and tolerability of low-dose oral minoxidil in patients with breast cancer and EIA.
II. To obtain preliminary data to support whether low-dose oral minoxidil is a reasonable alternative to topical minoxidil in patients with EIA.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients apply minoxidil foam topically to affected areas of the scalp once daily (QD) for up to 12 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive minoxidil orally (PO) QD for up to 12 months in the absence of disease progression or unacceptable toxicity.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm I (topical minoxidil)
Patients apply minoxidil foam topically to affected areas of the scalp QD for up to 12 months in the absence of disease progression or unacceptable toxicity.
Minoxidil
Applied topically
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (orally minoxidil)
Patients receive minoxidil PO QD for up to 12 months in the absence of disease progression or unacceptable toxicity.
Minoxidil
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Minoxidil
Applied topically
Minoxidil
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Established diagnosis of breast cancer stages I-IV
* On endocrine therapy including tamoxifen or aromatase inhibitors with or without concurrent use of ovarian function suppression
* Self-reporting hair loss since starting endocrine therapy
Exclusion Criteria
* Current chemotherapy use or prior chemotherapy use within the last 2 years
* History of scarring/cicatricial alopecia or alopecia areata
* Prior use of oral or topical minoxidil
* Prior or ongoing use of spironolactone
* Known sensitivity to minoxidil
* Untreated hypothyroidism or iron deficiency as determined by thyroid stimulating hormone (TSH) with reflex free T4 and ferritin level \> 40 to be checked at the time of enrolling if not completed in the 12 months prior
18 Years
FEMALE
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Brittany Dulmage
Principal Investigator
Principal Investigators
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Brittany L Dulmage, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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The Jamesline
Other Identifiers
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NCI-2021-01932
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-20340
Identifier Type: -
Identifier Source: org_study_id
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