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

15 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Ohio
      • Columbus, Ohio, Stati Uniti, 43210
        • Ohio State University Comprehensive Cancer Center
        • Investigatore principale:
          • Brittany L. Dulmage, MD
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Arm I (minoxidil)
Patients receive minoxidil topically to the scalp daily for 6 months in the absence of unacceptable toxicity.
Altro: Amministrazione del sondaggio
Studi accessori
Altro: Revisione del Fascicolo Sanitario Elettronico
Studi accessori
Droga: Minoxidil
Given topically
Altri nomi:
  • Rogaine
  • Alostil
  • Loniten
  • U10858
Sperimentale: 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.
Altro: Amministrazione del sondaggio
Studi accessori
Altro: Revisione del Fascicolo Sanitario Elettronico
Studi accessori
Droga: Minoxidil
Given topically
Altri nomi:
  • Rogaine
  • Alostil
  • Loniten
  • U10858
Dispositivo: Revian RED LED-light cap
Undergo low-level red-light therapy with Revian RED LED-light cap

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Dean scale score
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Dean scale score
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ohio State University Comprehensive Cancer Center

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

2 luglio 2026

Completamento primario (Stimato)

31 dicembre 2027

Completamento dello studio (Stimato)

31 dicembre 2027

Date di iscrizione allo studio

Primo inviato

16 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 maggio 2026

Primo Inserito (Effettivo)

19 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • OSU-24393
  • NCI-2026-02583 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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