Minoxidil With or Without Low-Level Red-Light Therapy for Improving Chemotherapy-Induced Alopecia in Breast Cancer Patients
30 de agosto de 2026 actualizado por: Brittany Dulmage, Ohio State University Comprehensive Cancer Center
A Pilot Study of Low-Level Red-Light Therapy Combined With Topical Minoxidil Compared With Topical Minoxidil Alone in Breast Cancer Patients With Chemotherapy-Induced Alopecia
This phase II trial compares the safety and effectiveness of topical minoxidil alone to topical minoxidil in combination with low-level red-light therapy for improving chemotherapy-induced hair loss or thinning (alopecia).
Minoxidil has been approved by the Food and Drug Administration as a treatment for hair loss.
It increases blood flow in the skin and may have a direct stimulatory effect on hair follicle cells, forcing them from their resting phase into their active growth phase.
Low-level light therapy is regarded as a safe and medically accepted treatment for a variety of skin conditions, including acne, scars, and psoriasis.
Red light wavelengths are readily absorbed into the skin and do not contain harmful ultraviolet light.
When absorbed into the skin, these wavelengths stimulate fibroblasts, which are connective tissue cells that make and secrete collagen proteins.
Low-level red-light therapy may improve hair loss by stimulating hair follicles.
Combining minoxidil with low-level red-light therapy may be safe and more effective at improving chemotherapy-induced alopecia than minoxidil alone.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
PRIMARY OBJECTIVE:
I. To determine the improvement in hair density as determined by the Dean scale score in patients with chemotherapy-induced alopecia following treatment with low-level light therapy (LLLT) and topical minoxidil versus topical minoxidil alone.
SECONDARY OBJECTIVES:
I. To determine the improvement in hair density and hair diameter as determined by trichoscopic evaluation in patients with chemotherapy-induced alopecia following treatment with LLLT and topical minoxidil versus topical minoxidil alone.
II. To determine the change in the quality-of-life Chemotherapy Alopecia Distress Scale (CADS) questionnaire score in patients with chemotherapy-induced alopecia following treatment with LLLT and topical minoxidil versus topical minoxidil alone.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive minoxidil topically to the scalp daily for 6 months in the absence of unacceptable toxicity.
ARM II: Patients receive minoxidil topically to the scalp daily and undergo low-level red-light therapy with the Revian RED LED-light cap over 10 minutes daily for 6 months in the absence of unacceptable toxicity.
After completion of study intervention, patients are followed up at 12 months.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
50
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: The Ohio State University Comprehensive Cancer Center
- Número de teléfono: 800-293-5066
- Correo electrónico: OSUCCCClinicaltrials@osumc.edu
Ubicaciones de estudio
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Ohio State University Comprehensive Cancer Center
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Investigador principal:
- Brittany L. Dulmage, MD
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Contacto:
- Brittany L. Dulmage, MD
- Número de teléfono: 614-293-1707
- Correo electrónico: Brittany.Dulmage@osumc.edu
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Patients will be Ohio State University patients > 18 years old
- Patients will have a diagnosis of breast cancer, stages I-IV
- Patients will have been treated with a chemotherapy regimen containing either an anthracycline or taxane
- Patients will have a loss of at least 50% of the hair on the scalp by the final chemotherapy infusion
- Patients will NOT be pregnant or nursing women
- Patients will NOT have a history of scarring/cicatricial alopecia or alopecia areata
- Patients will NOT have a known sensitivity to minoxidil
- Patients will NOT have ongoing treatment with an antibody-drug conjugate or immunotherapy
- NOTE: There is no exclusion criteria for utilization of scalp cooling
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Arm I (minoxidil)
Patients receive minoxidil topically to the scalp daily for 6 months in the absence of unacceptable toxicity.
|
Estudios complementarios
Estudios complementarios
Given topically
Otros nombres:
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Experimental: Arm II (minoxidil, LLLT)
Patients receive minoxidil topically to the scalp daily and undergo low-level red-light therapy with the Revian RED LED-light cap over 10 minutes daily for 6 months in the absence of unacceptable toxicity.
|
Estudios complementarios
Estudios complementarios
Given topically
Otros nombres:
Undergo low-level red-light therapy with Revian RED LED-light cap
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Dean scale score
Periodo de tiempo: After 6 months of intervention
|
The Dean scale measures hair loss along a 4-grade scale.
Grade 1 = <25% hair loss.
Grade 2= 25-50% hair loss.
Grade 3=50-75% hair loss.
Grade 4 = >75% hair loss.
Success will be defined as Dean scale score of 1 or 0. This will be based on clinical photographs taken at the initial and 6-month visits and scored by two board-certified dermatologists.
Will construct two-sided 95% confidence intervals for improvement from baseline and differences between randomized groups, including the proportion of patients with a Dean score of 1 or 0 at 6 months.
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After 6 months of intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Dean scale score
Periodo de tiempo: From baseline to 2, 4, and 12 months
|
The Dean scale measures hair loss along a 4-grade scale.
Grade 1 = <25% hair loss.
Grade 2= 25-50% hair loss.
Grade 3=50-75% hair loss.
Grade 4 = >75% hair loss.Will be reported by treatment group using summary statistics (mean and standard deviation, median and quartiles, or count and percentage, as appropriate).
Will construct two-sided 95% confidence intervals for improvement from baseline and differences between randomized groups.
|
From baseline to 2, 4, and 12 months
|
|
Change in trichoscopic hair density
Periodo de tiempo: From baseline to 2, 4, 6, and 12 months
|
Measures of hair density will be taken via trichoscopic photography by use of the HairMetrix device.
Density measurements will be reported by treatment group using summary statistics (mean and standard deviation, median and quartiles, or count and percentage, as appropriate).
Will construct two-sided 95% confidence intervals for improvement from baseline and differences between randomized groups.
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From baseline to 2, 4, 6, and 12 months
|
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Change in Chemotherapy Alopecia Distress Scale (CADS)
Periodo de tiempo: From baseline to 2, 4, 6, and 12 months
|
CADS is a 17-item tool that measures hair loss distress. Each question uses a 4-point likert scale (0-3), and total scores range from 0-51 with higher scores indicating greater hair loss distress. Longitudinal mixed effects linear and generalized linear or logistic models will be used with improvement from baseline as the outcome at 2, 4, 6, and 12 months. Randomization group, time point, and their interaction will be used as fixed effects, and a subject random effect will be used to account for within-subject correlation of outcomes. For CADS, baseline score will also be included as a fixed effect. TWill be reported by treatment group using summary statistics (mean and standard deviation, median and quartiles, or count and percentage, as appropriate). Will construct two-sided 95% confidence intervals for improvement from baseline and differences between randomized groups. |
From baseline to 2, 4, 6, and 12 months
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Change in patient reported outcomes (hair loss survey)
Periodo de tiempo: From baseline to 2, 4, 6, and 12 months
|
Participants will be asked four questions about symptoms related to hair loss over the last week.
Each question is scored on a scale with possible answers ranging from 0 (not present) to 10 (as bad as you can imagine).
Will be reported by treatment group using summary statistics (mean and standard deviation, median and quartiles, or count and percentage, as appropriate).
Will construct two-sided 95% confidence intervals for improvement from baseline and differences between randomized groups.
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From baseline to 2, 4, 6, and 12 months
|
|
Change in patient reported outcomes (feelings survey)
Periodo de tiempo: From baseline to 2, 4, 6, and 12 months
|
Participants will be asked four questions about their general feelings over the last week.
Each question is scored on a scale with possible answers ranging from 0 (as bad as it can be) to 10 (as good as it can be).
Will be reported by treatment group using summary statistics (mean and standard deviation, median and quartiles, or count and percentage, as appropriate).
Will construct two-sided 95% confidence intervals for improvement from baseline and differences between randomized groups.
|
From baseline to 2, 4, 6, and 12 months
|
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Differences in patient satisfaction (feasibility)
Periodo de tiempo: At 2, 4, and 6 months
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Differences in patient satisfaction will be used to determine differences in feasibility between the two treatment arms.
Participants will be asked five questions about their satisfaction with hair changes and study treatment over the last two months.
Each question will be scored on a scale ranging from 0 (not satisfied at all) to 10 (as satisfied as I can be).
Will be reported by treatment group using summary statistics (mean and standard deviation, median and quartiles, or count and percentage, as appropriate).
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At 2, 4, and 6 months
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Compliance
Periodo de tiempo: At 2, 4, and 6 months
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Differences in medication administration logs will be used to determine differences in compliance between the two treatment arms.
For the topical minoxidil group, the proportions of days medication was applied will be reported.
For the low-level red-light therapy + minoxidil group, the proportions of days minoxidil was applied as well as the proportions of weeks that the low-level red-light therapy was used will be reported.
Will be reported by treatment group using summary statistics (mean and standard deviation, median and quartiles, or count and percentage, as appropriate).
|
At 2, 4, and 6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Brittany L Dulmage, MD, Ohio State University Comprehensive Cancer Center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de noviembre de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
16 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
15 de mayo de 2026
Publicado por primera vez (Actual)
19 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
30 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- OSU-24393
- NCI-2026-02583 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
No
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