Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Cancer
Primary Purpose
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Minoxidil
Minoxidil
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
About this trial
This is an interventional treatment trial for Anatomic Stage I Breast Cancer AJCC v8
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
Sites / Locations
- Ohio State University Comprehensive Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm I (topical minoxidil)
Arm II (orally minoxidil)
Arm Description
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.
Outcomes
Primary Outcome Measures
Proportion of days assigned medication was taken/applied
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.
Secondary Outcome Measures
Occurrence of at least one adverse event (AE) of grade 1 or higher
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.
Change in hair density
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.
Change in hair density
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.
Change in hair density
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.
Chemotherapy Alopecia Distress Scale (CADS) score
Patients will complete a a self-administered 17-item questionnaire
CADS score physical
a self-administered 17-item questionnaire which categorizes questions into 4 subscales including physical
CADS score physical
a self-administered 17-item questionnaire which categorizes questions into 4 subscales including physical relationship
CADS score emotional
a self-administered 17-item questionnaire which categorizes questions into 4 subscales including emotional relationship
Patient-reported outcomes
Mean responses to the symptom experience diary questions and the satisfaction items will be compared between groups via t-test.
Patient-reported outcomes
Mean responses to the symptom experience diary questions and the satisfaction items will be compared between groups via t-test.
Patient-reported outcomes
Mean responses to the symptom experience diary questions and the satisfaction items will be compared between groups via t-test.
Full Information
NCT ID
NCT05417308
First Posted
March 16, 2021
Last Updated
March 8, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05417308
Brief Title
Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Cancer
Official Title
A Pilot Trial of Topical vs Oral Minoxidil for Treatment of Endocrine Therapy-Induced Alopecia in Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Endocrine Therapy-Induced Alopecia, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage IV Breast Cancer AJCC v8
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I (topical minoxidil)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm II (orally minoxidil)
Arm Type
Experimental
Arm Description
Patients receive minoxidil PO QD for up to 12 months in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Minoxidil
Other Intervention Name(s)
Alostil, Loniten, Rogaine, U 10858
Intervention Description
Applied topically
Intervention Type
Drug
Intervention Name(s)
Minoxidil
Other Intervention Name(s)
Alostil, Loniten, Rogaine, U 10858
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Proportion of days assigned medication was taken/applied
Description
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.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Occurrence of at least one adverse event (AE) of grade 1 or higher
Description
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.
Time Frame
Up to 12 months
Title
Change in hair density
Description
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.
Time Frame
Baseline to 3 months
Title
Change in hair density
Description
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.
Time Frame
Baseline to 6 months
Title
Change in hair density
Description
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.
Time Frame
Baseline to 12 months
Title
Chemotherapy Alopecia Distress Scale (CADS) score
Description
Patients will complete a a self-administered 17-item questionnaire
Time Frame
At 3 months
Title
CADS score physical
Description
a self-administered 17-item questionnaire which categorizes questions into 4 subscales including physical
Time Frame
At 6 months
Title
CADS score physical
Description
a self-administered 17-item questionnaire which categorizes questions into 4 subscales including physical relationship
Time Frame
At 6 months
Title
CADS score emotional
Description
a self-administered 17-item questionnaire which categorizes questions into 4 subscales including emotional relationship
Time Frame
At 12 months
Title
Patient-reported outcomes
Description
Mean responses to the symptom experience diary questions and the satisfaction items will be compared between groups via t-test.
Time Frame
At 3 months
Title
Patient-reported outcomes
Description
Mean responses to the symptom experience diary questions and the satisfaction items will be compared between groups via t-test.
Time Frame
At 6 months
Title
Patient-reported outcomes
Description
Mean responses to the symptom experience diary questions and the satisfaction items will be compared between groups via t-test.
Time Frame
At 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
The Ohio State University Comprehensive Cancer Center
Phone
800-293-5066
Email
OSUCCCClinicaltrials@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brittany L Dulmage, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany L. Dulmage, MD
Phone
614-565-2554
Email
brittany.dulmage@osumc.edu
First Name & Middle Initial & Last Name & Degree
Brittany L. Dulmage, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline
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Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Cancer
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