Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Minoxidil, Minoxidil, Quality-of-Life Assessment, Questionnaire Administration.
- Who it may be relevant to
- Registry conditions: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pilot Trial of Topical vs Oral Minoxidil for Treatment of Endocrine Therapy-Induced Alopecia in Breast Cancer Patients
Overview
This early phase I trial studies the possible benefits and/or side effects of topical or oral minoxidil in treating endocrine therapy-induced hair loss (alopecia) in patients with stage I-IV breast cancer. Endocrine therapy-induced alopecia (EIA) is a distressing side effect that leads to reduced quality of life and early cessation of therapy in women undergoing treatment for breast cancer. Patients on endocrine therapy commonly report hair loss or thinning. Minoxidil is a drug that may promote hair growth and reduce hair loss. Oral minoxidil may increase hair density in women with EIA, and work the same as topical minoxidil in treating EIA in patients with breast cancer.
Detailed description
PRIMARY OBJECTIVES:
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.
Interventions
- Drug Minoxidil
Applied topically - Drug Minoxidil
Given PO - Other Quality-of-Life Assessment
Ancillary studies - Other Questionnaire Administration
Ancillary studies
Primary outcome measures
- Proportion of days assigned medication was taken/applied [Time frame: Up to 12 months]
Secondary outcome measures (11)
- Occurrence of at least one adverse event (AE) of grade 1 or higher [Time frame: Up to 12 months]
- Change in hair density [Time frame: Baseline to 3 months]
- Change in hair density [Time frame: Baseline to 6 months]
- Change in hair density [Time frame: Baseline to 12 months]
- Chemotherapy Alopecia Distress Scale (CADS) score [Time frame: At 3 months]
- CADS score physical [Time frame: At 6 months]
- CADS score physical [Time frame: At 6 months]
- CADS score emotional [Time frame: At 12 months]
- Patient-reported outcomes [Time frame: At 3 months]
- Patient-reported outcomes [Time frame: At 6 months]
- Patient-reported outcomes [Time frame: At 12 months]
Eligibility criteria
Inclusion criteria
- Women >= 18 years of age
- 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
- Pregnant or nursing women
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Ohio State University Comprehensive Cancer Center — Columbus
Identifiers
NCT: NCT05417308 · OSU-20340 · NCI-2021-01932