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RecruitingEarly Phase 1

Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Cancer

A Pilot Trial of Topical vs Oral Minoxidil for Treatment of Endocrine Therapy-Induced Alopecia in Breast Cancer Patients

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the benefits and side effects of minoxidil taken by mouth or put on the scalp to treat hair loss. It is for women with stage I–IV (1–4) breast cancer who have hair loss after starting hormone therapy.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 18 or older.
  • Have stage I–IV (1–4) breast cancer.
  • Take hormone therapy, such as tamoxifen or aromatase inhibitors, with or without treatment to stop the ovaries from making hormones.
  • Report hair loss that started after beginning hormone therapy.

Who can't join

  • Are pregnant or breastfeeding.
  • Are getting chemotherapy now or had it within the past 2 years.
  • Have a history of hair loss that causes scarring, or alopecia areata, which causes patchy hair loss.
  • Have ever used minoxidil by mouth or on the scalp.
  • Use or have used spironolactone.
  • Have a known sensitivity to minoxidil.
  • Have an untreated underactive thyroid or low iron. Blood tests are checked at enrollment if not done in the past 12 months.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

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