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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
Clinical treatment response will be scored by a blinded investigator.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •for utilization of scalp cooling
研究组 & 干预措施
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.
干预措施: Revian RED LED-light cap (Device)
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.
干预措施: Survey Administration (Other)
Arm I (minoxidil)
Patients receive minoxidil topically to the scalp daily for 6 months in the absence of unacceptable toxicity.
干预措施: Minoxidil (Drug)
Arm I (minoxidil)
Patients receive minoxidil topically to the scalp daily for 6 months in the absence of unacceptable toxicity.
干预措施: Electronic Health Record Review (Other)
Arm I (minoxidil)
Patients receive minoxidil topically to the scalp daily for 6 months in the absence of unacceptable toxicity.
干预措施: Survey Administration (Other)
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.
干预措施: Electronic Health Record Review (Other)
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.
干预措施: Minoxidil (Drug)
研究者
Brittany Dulmage
Principal Investigator
Ohio State University Comprehensive Cancer Center