Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia

  • STATUS
    Recruiting
  • End date
    Dec 14, 2022
  • participants needed
    25
  • sponsor
    Northwestern University
Updated on 14 June 2022

Summary

An open label, pilot study involving the use of low dose oral minoxidil to treat permanent chemotherapy-induced alopecia.

Description

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.

Details
Condition Permanent Chemotherapy-induced Alopecia
Treatment oral minoxidil
Clinical Study IdentifierNCT03831334
SponsorNorthwestern University
Last Modified on14 June 2022

Eligibility

Yes No Not Sure

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 >
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
Female patients who are pregnant or nursing 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
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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