Minoxidil With or Without Low-Level Red-Light Therapy for Improving Chemotherapy-Induced Alopecia in Breast Cancer Patients
30. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
50
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: The Ohio State University Comprehensive Cancer Center
- Telefonnummer: 800-293-5066
- E-Mail: OSUCCCClinicaltrials@osumc.edu
Studienorte
-
-
Ohio
-
Columbus, Ohio, Vereinigte Staaten, 43210
- Ohio State University Comprehensive Cancer Center
-
Hauptermittler:
- Brittany L. Dulmage, MD
-
Kontakt:
- Brittany L. Dulmage, MD
- Telefonnummer: 614-293-1707
- E-Mail: Brittany.Dulmage@osumc.edu
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Arm I (minoxidil)
Patients receive minoxidil topically to the scalp daily for 6 months in the absence of unacceptable toxicity.
|
Nebenstudien
Nebenstudien
Given topically
Andere Namen:
|
|
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.
|
Nebenstudien
Nebenstudien
Given topically
Andere Namen:
Undergo low-level red-light therapy with Revian RED LED-light cap
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Dean scale score
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Dean scale score
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Brittany L Dulmage, MD, Ohio State University Comprehensive Cancer Center
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
15. November 2026
Primärer Abschluss (Geschätzt)
31. Dezember 2027
Studienabschluss (Geschätzt)
31. Dezember 2027
Studienanmeldedaten
Zuerst eingereicht
16. April 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
15. Mai 2026
Zuerst gepostet (Tatsächlich)
19. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
2. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
30. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- OSU-24393
- NCI-2026-02583 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Ja
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Ja
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
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