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Minoxidil With or Without Low-Level Red-Light Therapy for Improving Chemotherapy-Induced Alopecia in Breast Cancer Patients

30 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Ohio
      • Columbus, Ohio, Verenigde Staten, 43210
        • Ohio State University Comprehensive Cancer Center
        • Hoofdonderzoeker:
          • Brittany L. Dulmage, MD
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Arm I (minoxidil)
Patients receive minoxidil topically to the scalp daily for 6 months in the absence of unacceptable toxicity.
Ander: Enquête Administratie
Nevenstudies
Ander: Beoordeling van elektronische medische dossiers
Nevenstudies
Geneesmiddel: Minoxidil
Given topically
Andere namen:
  • Rogaine
  • Alostil
  • Loniten
  • U 10858
Experimenteel: 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.
Ander: Enquête Administratie
Nevenstudies
Ander: Beoordeling van elektronische medische dossiers
Nevenstudies
Geneesmiddel: Minoxidil
Given topically
Andere namen:
  • Rogaine
  • Alostil
  • Loniten
  • U 10858
Apparaat: Revian RED LED-light cap
Undergo low-level red-light therapy with Revian RED LED-light cap

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Dean scale score
Tijdsspanne: 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.
After 6 months of intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Dean scale score
Tijdsspanne: 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
Tijdsspanne: 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.
From baseline to 2, 4, 6, and 12 months
Change in Chemotherapy Alopecia Distress Scale (CADS)
Tijdsspanne: 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
Change in patient reported outcomes (hair loss survey)
Tijdsspanne: 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.
From baseline to 2, 4, 6, and 12 months
Change in patient reported outcomes (feelings survey)
Tijdsspanne: 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
Differences in patient satisfaction (feasibility)
Tijdsspanne: At 2, 4, and 6 months
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).
At 2, 4, and 6 months
Compliance
Tijdsspanne: At 2, 4, and 6 months
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ohio State University Comprehensive Cancer Center

Onderzoekers

  • Hoofdonderzoeker: Brittany L Dulmage, MD, Ohio State University Comprehensive Cancer Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 november 2026

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

16 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

15 mei 2026

Eerst geplaatst (Werkelijk)

19 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 september 2026

Laatste update ingediend die voldeed aan QC-criteria

30 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • OSU-24393
  • NCI-2026-02583 (Register-ID: CTRP (Clinical Trial Reporting Program))

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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