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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Electronic Health Record Review
  Ancillary studies
• Препарат Minoxidil
  Given topically
• Устройство Revian RED LED-light cap
  Undergo low-level red-light therapy with Revian RED LED-light cap
• Другое Survey Administration
  Ancillary studies

Первичные конечные точки

• Dean scale score [Срок оценки: After 6 months of intervention]

Вторичные конечные точки (7)

• Change in Dean scale score [Срок оценки: From baseline to 2, 4, and 12 months]
• Change in trichoscopic hair density [Срок оценки: From baseline to 2, 4, 6, and 12 months]
• Change in Chemotherapy Alopecia Distress Scale (CADS) [Срок оценки: From baseline to 2, 4, 6, and 12 months]
• Change in patient reported outcomes (hair loss survey) [Срок оценки: From baseline to 2, 4, 6, and 12 months]
• Change in patient reported outcomes (feelings survey) [Срок оценки: From baseline to 2, 4, 6, and 12 months]
• Differences in patient satisfaction (feasibility) [Срок оценки: At 2, 4, and 6 months]
• Compliance [Срок оценки: At 2, 4, and 6 months]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Ohio State University Comprehensive Cancer Center — Columbus

Идентификаторы

NCT: NCT07594678 · OSU-24393 · NCI-2026-02583

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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