Skin and Connective Tissue Diseases

Symptoms and General Pathology

All Conditions

Alopecia

Alopecia Areata

Hypotrichosis

Hair Diseases

Skin Diseases

Pathological Conditions, Anatomical

Antihypertensive Agents

Vasodilator Agents

All Drugs and Chemicals

Minoxidil

Patients receive oral minoxidil at a dose of 0.01 (\<40kg) and 0.02 (≥40kg) mg/kg/day for 8 months

Patient receive placebo for 4 months followed by oral minoxidil for 4 months

minoxidil at a dose of 0.01 (\<40kg) and 0.02 (≥40kg) mg/kg/day

Oral Minoxidil

Placebo

Alina Markova, MD

Danielle Friedman, MD

This study will test whether minoxidil taken by mouth (oral minoxidil) can improve hair loss caused by cancer treatment in children and young adults. In addition, the researchers will test the safety of oral minoxidil, and see if the study drug causes few or mild side effects in participants. Other purposes of this study include looking at whether participants are able to follow their study drug dosing schedules, and how oral minoxidil affects participants' quality of life.

A Study of Oral Minoxidil to Treat Hair Loss in Children, Teens, and Young Adults Who Are Cancer Survivors

A Pilot Study of Oral Minoxidil for the Treatment of Persistent Hair Loss in Pediatric, Adolescent, and Young Adult Cancer Survivors

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

as assessed by Hairmetrix allows trichoscopy (dermoscopic imaging of the scalp and hair) in real time. It requires no special scalp or hair preparation and allows fully automated unclipped analysis, producing measurements.

Memorial Sloan Kettering Cancer Center

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Participants in this arm will be treated with minoxidil. This treatment will be given daily by mouth.

Minoxidil is an antihypertensive vasodilator medication commonly used for the treatment of high blood pressure and pattern hair loss.

Margaret Liotta, DO

Mary Beth Bartolotta, RN

The primary purpose of this study is to determine the response rate of patients with recurrent platinum resistant ovarian cancer when treated with oral minoxidil. Secondary objectives include estimating the time to disease progression while on minoxidil and to describe the toxicities of minoxidil when used for patients with recurrent platinum resistant ovarian cancer. An exploratory objective is to evaluate if efficacy of minoxidil is improved in patients that have the Kir6/SUR complex versus those that do not.

Minoxidil is approved by the Food and Drug Administration (FDA) for treatment of hypertension. In previous studies, the sulfonylurea receptor (SUR) subunit controls the selectivity of the pharmacological response to drugs that either inhibit or stimulate the Kir6/SUR channel. Oral minoxidil acts as an activator of the Kir6/SUR2 channel upon selective binding to sulfonylurea receptor 2 (SUR2). Activation of the Kir6.2 potassium channel by minoxidil leads to potassium outflow and calcium entry which produces a cytoplasmic electrical charge that is more negative. This in turn creates an attractive force for calcium to enter the cell. Increased intracellular calcium disrupts mechanisms of cell division by arresting the cell cycle in G2/M phase and this is associated with alteration of the oxidative state, disruption of the mitochondria and activation of the caspase-3-independent cell death pathway.

Evaluation of arrest of tumor growth was evaluated in a previous study. This was done in vitro as well as in vivo by establishing a xenograft model from a Kir6.2/SUR2 positive high grade serous ovarian cancer cell line. In the mice treated with minoxidil, five of the 6 mice had no evidence of measurable disease at necropsy. In contrast, the untreated mice were found to have carcinomatosis and ascites in all 6 mice, demonstrating tumor reduction with minoxidil treatment.

While recurrent ovarian cancer can be treated with a multitude of drugs, the response rates are limited. Treatment options can also be limited secondary to myelosuppression as a result of patients being heavily pretreated. Minoxidil appears to have the advantage of not causing severe myelosuppression which can limit treatment options for patients. Laboratory results provide promising evidence that minoxidil could be used for the treatment of recurrent ovarian cancer.

This study plans to conduct a single center phase II study to evaluate the efficacy and safety of oral minoxidil in the treatment of platinum resistant ovarian cancer. The primary goal is to assess whether treatment with minoxidil will reduce tumor burden in patients with recurrent ovarian cancer and have a minimal toxicity profile.

This is a non-randomized prospective single-site trial of minoxidil for patients living with recurrent platinum resistant ovarian cancer.

This study is an open-label Phase II trial

Oral Minoxidil for the Treatment of Recurrent Platinum Resistant Epithelial Ovarian Cancer

A Phase II Trial of Oral Minoxidil for the Treatment of Recurrent Platinum Resistant Epithelial Ovarian Cancer

There is no plan to share individual participant data with other researchers.

The ORR is defined as the percentage of participants who experience a complete response (CR), partial response (PR), or stable disease (SD) as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0)

PFS is defined as the time from receipt of minoxidil to the first documented progression of disease or death due to any cause, whichever occurred first

Cures Within Reach

Medical University of South Carolina

Loyola University

Associate Professor

Breast Neoplasms

Breast Diseases

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.

Patients receive minoxidil PO QD for up to 12 months in the absence of disease progression or unacceptable toxicity.

Quality-of-Life Assessment

Questionnaire Administration

The Ohio State University Comprehensive Cancer Center

Brittany L. Dulmage, MD

Brittany L Dulmage, MD

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.

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.

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

For the oral minoxidil group, the proportion of pills taken will be reported with a 95% confidence interval. For the topical minoxidil group, the proportions of days medication was applied will be reported with a 95% confidence interval.

Adverse events will be summarized using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 with reporting of the number and percentage of patients affected. The total number of participants with AEs of any grade, and the total number of participants with grade 3 or higher AEs will be compared between randomized groups using Fisher's exact test.

At least mild-to-moderate improvement in hair density from baseline to 3 months as determined by a board-certified dermatologist from photographs. Will construct two-sided 95% confidence intervals for improvements from baseline and differences between randomized groups. Response will be dichotomized as no improvement versus moderate-to-significant improvement.

At least mild-to-moderate improvement in hair density from baseline to 6 months as determined by a board-certified dermatologist from photographs. Will construct two-sided 95% confidence intervals for improvements from baseline and differences between randomized groups. Response will be dichotomized as no improvement versus moderate-to-significant improvement.

At least mild-to-moderate improvement in hair density from baseline to 12 months as determined by a board-certified dermatologist from photographs. Will construct two-sided 95% confidence intervals for improvements from baseline and differences between randomized groups. Response will be dichotomized as no improvement versus moderate-to-significant improvement.

Patients will complete a a self-administered 17-item questionnaire

a self-administered 17-item questionnaire which categorizes questions into 4 subscales including physical

a self-administered 17-item questionnaire which categorizes questions into 4 subscales including physical relationship

a self-administered 17-item questionnaire which categorizes questions into 4 subscales including emotional relationship

Mean responses to the symptom experience diary questions and the satisfaction items will be compared between groups via t-test.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Oral Minoxidil to Treat Hair Loss in Children, Teens, and Young Adults Who Are Cancer Survivors	NCT05778825	Survivors of Ch... Alopecia	Oral Minoxidil Placebo	6 Years - 18 Years	Memorial Sloan Kettering Cancer Center
Oral Minoxidil for the Treatment of Recurrent Platinum Resistant Epithelial Ovarian Cancer	NCT05272462	Ovarian Cancer	Minoxidil	18 Years - 90 Years	Loyola University
A Study of Oral Minoxidil to Treat Hair Loss in Children, Teens, and Young Adults Who Are Cancer Survivors	NCT05778825	Survivors of Ch... Alopecia	Oral Minoxidil Placebo	6 Years - 18 Years	Memorial Sloan Kettering Cancer Center
Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Cancer	NCT05417308	Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Endocrine Thera... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag...	Minoxidil Minoxidil Quality-of-Life... Questionnaire A...	18 Years -	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for minoxidil

Every month we try and update this database with for minoxidil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for minoxidil

Every month we try and update this database with for minoxidil cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for minoxidil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.