Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia
Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia
An open label, pilot study involving the use of low dose oral minoxidil to treat permanent
 chemotherapy-induced alopecia.
Patients will be evaluated through clinical assessment, histology, quality of life
 assessment, and adverse event monitoring. The data gathered from this study will be used to
 determine the safety and efficacy of the treatment regimen for this subset of CIA patients.
 The oral minoxidil regimen will be considered effective if significant clinical regrowth,
 positive histological changes, and improved Quality of Life are reported after the onset of
 treatment.
Inclusion Criteria:

 -  Patients with a clinical diagnosis of permanent chemotherapy-induced alopecia who
 completed chemotherapy ≥ 6 months from the date of registration.

 -  Patients must be age ≥ 18 years.

 -  Females of child-bearing potential (FOCBP) and males must agree to use adequate
 contraception (e.g., hormonal contraceptives such as birth control pills, patch,
 intrauterine device; barrier contraception such as male/female condoms, diaphragm;
 male partner with vasectomy; abstinence) prior to study entry, for the duration of
 study participation, and for 30 days following completion of therapy.

 Should a female patient become pregnant or suspect she is pregnant while participating in
 this study, she should inform her treating physician immediately.

 NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal
 ligation, or remaining celibate by choice) who meets the following criteria: Has not
 undergone a hysterectomy or bilateral oophorectomy Has had menses at any time in the
 preceding 12 consecutive months (and therefore has not been naturally postmenopausal for >
 12 months)

 -  FOCBP must have a negative urine or serum pregnancy test within 7 days prior to
 registration on study.

 -  Patients must have the ability to understand and the willingness to sign a written
 informed consent prior to registration in the study.

 Exclusion Criteria:

 -  Patients receiving any other investigational agents or using other alopecia treatments
 in the past 3 months are not eligible.

 -  Patients currently undergoing systemic cancer treatment or within 6 months of
 finishing chemotherapy are not eligible. Note: Patients receiving hormone modulators
 are eligible.

 -  Patients who have pheochromocytoma, hypothyroidism, anemia, cutaneous GVHD,
 hypotension, or a history of hypersensitivity to any components of the drug
 preparation are not eligible.

 -  Patients who have other forms of alopecia besides PCIA (with the exception of female
 pattern Ludwig 1 alopecia) are not eligible.

 -  Patients on oral or injectable anticoagulants are not eligible to participate in the
 optional punch biopsy

 -  Patients who have an uncontrolled intercurrent illness including, but not limited to
 any of the following, are not eligible: (Uncontrolled Hypertension, Ongoing or active
 infection requiring systemic treatment, Symptomatic congestive heart failure, Unstable
 angina pectoris, Cardiac arrhythmia, Pericardial effusion, Psychiatric illness/social
 situations that would limit compliance with study requirements, Patients with any
 other illness or condition that the treating investigator feels would interfere with
 study compliance or would compromise the patient's safety or study endpoints.)

 -  Patients currently taking guanethidine are not eligible. Patients may participate
 after a 1-week washout period.

 -  Patients currently taking drugs that may enhance the hypotensive effect of minoxidil
 are not eligible. Please contact study team regarding specific drug as washout period,
 as this will vary. Note: This includes: Alfuzosin, Amifostine, antipsychotic agents,
 Atazanavir, barbiturates, Benperidol, Brimonidine, Dapoxetine, Diazoxide, DULoxetine,
 Levodopa, Lormetazepam, Molsidomine, Naftopidil, Nicergoline, Nicorandil,
 Nitroprusside, Obinutuzumab, Pentoxifylline, phosphodiesterase 5 inhibitors,
 Probenecid, prostacyclin analogues, Quinagolide, and Valproate. If a patient is
 currently taking any of these drugs, further evaluation will be required to determine
 eligibility.

 -  Female patients who are pregnant or nursing are not eligible.

 -  Patients who have any condition or situation which, in the investigator's opinion,
 puts the patient at significant risk, could confound the study results, or may
 interfere significantly with the patient's participation in the study are not
 eligible.

 -  Patients who are unable to communicate or cooperate with the investigator due to
 language problems, poor mental development, or impaired cerebral function are not
 eligible.