Minoxidil With or Without Low-Level Red-Light Therapy for Improving Chemotherapy-Induced Alopecia in Breast Cancer Patients
30. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
50
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: The Ohio State University Comprehensive Cancer Center
- Telefonnummer: 800-293-5066
- E-post: OSUCCCClinicaltrials@osumc.edu
Studiesteder
-
-
Ohio
-
Columbus, Ohio, Forente stater, 43210
- Ohio State University Comprehensive Cancer Center
-
Hovedetterforsker:
- Brittany L. Dulmage, MD
-
Ta kontakt med:
- Brittany L. Dulmage, MD
- Telefonnummer: 614-293-1707
- E-post: Brittany.Dulmage@osumc.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Arm I (minoxidil)
Patients receive minoxidil topically to the scalp daily for 6 months in the absence of unacceptable toxicity.
|
Hjelpestudier
Hjelpestudier
Given topically
Andre navn:
|
|
Eksperimentell: 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.
|
Hjelpestudier
Hjelpestudier
Given topically
Andre navn:
Undergo low-level red-light therapy with Revian RED LED-light cap
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Dean scale score
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Dean scale score
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Brittany L Dulmage, MD, Ohio State University Comprehensive Cancer Center
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
15. november 2026
Primær fullføring (Antatt)
31. desember 2027
Studiet fullført (Antatt)
31. desember 2027
Datoer for studieregistrering
Først innsendt
16. april 2026
Først innsendt som oppfylte QC-kriteriene
15. mai 2026
Først lagt ut (Faktiske)
19. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- OSU-24393
- NCI-2026-02583 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Nei
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