Effect of Helmet Type, Home-use Photobiomodulation Therapy Device for Chemotherapy-induced Alopecia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Hair counts recorded by Sentra scalp analyzer
研究概览
简要总结
As far as breast cancer is concerned, chemotherapy (CT) is an important treatment. However, there are many adverse effects impairing the patient's quality of life (QOL), in which chemotherapy-induced alopecia (CIA) affects up to 65% of the patients. This condition is reversible. Nevertheless, it takes several months after CT for visible hair regrowth. Different characteristics of the new hair are common; for example, 65 percent of the patients have experienced a graying, curling, or straightening effect. Besides, the emotional trauma due to alopecia can not be neglected.
Currently, scalp cooling is the only available and verified management for prevention. Unfortunately, the success rate of scalp cooling is variable, especially among the patients receiving anthracycline-based combinations.
Low-level light therapy (LLLT) has been proven as a therapeutic technique for adrenergic alopecia. Recently, investigators have checked the validity of LLLT for the CIA. Although the preliminary outcome showed failure at accelerating hair recovery, technical progress of LLLT may improve the end result. Specifically, LLLT is a technique that utilizes laser diodes (LD) or light-emitting diodes (LED) to promote tissue repair. The light source from LD is coherent while LED is an incoherent light source. Therefore, LDs can deliver energy to tissues more efficiently than LEDs. To comprehensively evaluate the beneficial effect of LLLT in treating CIA, we conduct a clinical trial with a more advanced device equipped with 69 LDs.
The project aims to explore the effect of low-level light therapy in chemotherapy-induced alopecia. We expect the therapy will lead to an improvement in the patient's hair count, hair width, and quality of life after chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 20 to 75 years
- •Informed Consent as documented by signature.
- •Able to read and converse in chinese
- •Diagnosis of breast cancer
- •They completed chemotherapy no more than 2 weeks
- •Treatment with neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy: anthracycline and taxane containing (paclitaxel or docetaxel) chemotherapy regimen.
- •life expectancy was at least 6 months.
- •Diagnosed with CIA grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE)
排除标准
- •scalp tumor or melanoma
- •having any serious mental illness or history, or taking psychotropic drugs
- •a medical history of dermatosis
- •severe liver and kidney damage
- •Pregnancy
- •Take any of the following medications for 6 months prior to initiation of the study: topical minoxidil, and spironolactone, and topical calcitriol
- •Receiving scalp cooling during chemotherapy
结局指标
主要结局
Hair counts recorded by Sentra scalp analyzer
时间窗: 12th course of intervention (four weeks after the first course of intervention)
Sentra scalp analyzer is an innovative phototrichogram, combining the technique of trichoscopy, image capture, and image interpretation. This device can be utilized to measure hair counts and hair width. We will record hair counts in the frontal, parietal, and occipital regions.
Hair counts recorded by Sentra scalp analyzer
时间窗: Baseline
Sentra scalp analyzer is an innovative phototrichogram, combining the technique of trichoscopy, image capture, and image interpretation. This device can be utilized to measure hair counts and hair width. We will record hair counts in the frontal, parietal, and occipital regions.
次要结局
- Chemotherapy-Induced Alopecia Distress Scale(12th course of intervention (four weeks after the first course of intervention))
- European Quality of Life 5 Dimensions 5 Level Version(12th course of intervention (four weeks after the first course of intervention))
- European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire(12th course of intervention (four weeks after the first course of intervention))
- Hair width recorded by Sentra scalp analyzer(9th course of intervention (three weeks after the first course of intervention))
- Hair counts recorded by Sentra scalp analyzer(9th course of intervention (three weeks after the first course of intervention))
- Rosenberg Self-esteem Scale(12th course of intervention (four weeks after the first course of intervention))
- Hair width recorded by sentra scalp analyzer(12th course of intervention (four weeks after the first course of intervention))
- Chemotherapy-Induced Alopecia Distress Scale(Baseline)
- Rosenberg Self-esteem Scale(Baseline)
- European Quality of Life 5 Dimensions 5 Level Version(Baseline)
- European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire(Baseline)
- Hair width recorded by Sentra scalp analyzer(Baseline)
- Hair counts recorded by Sentra scalp analyzer(3rd course of intervention (one week after the first course of intervention))
- Hair width recorded by Sentra scalp analyzer(3rd course of intervention (one week after the first course of intervention))
- Hair counts recorded by Sentra scalp analyzer(6th course of intervention (two weeks after the first course of intervention))
- Hair width recorded by Sentra scalp analyzer(6th course of intervention (two weeks after the first course of intervention))
研究者
YUAN-CHIEH YEH
Deputy Director, Assistant professor
Chang Gung Memorial Hospital