Evaluating the Feasibility and Efficacy of Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-induced Alopecia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- CTCAE-score
研究概览
简要总结
This study aims to investigate the effectiveness of photobiomodulation therapy (PBM) in the prevention and management of chemotherapy-induced alopecia (CIA). Therefore, we hypothesize that PBMT can reduce the severity of CIA in gynecological and breast cancer patients, increasing the patient's QoL.
详细描述
The global cancer burden keeps rising, and the accompanied side effects remain a significant concern. This project focuses on one of such complications: chemotherapy-induced alopecia (CIA). 65% of cancer patients receiving cytotoxic drugs experience CIA, which negatively impacts their QoL, as hair loss is often associated with impaired body image and increased depression rates. Up to now, prevention of CIA is based on scalp cooling, but this treatment has a highly variable success rate. Photobiomodulation (PBM) therapy is a non-invasive form of phototherapy that utilizes visible and/or near-infrared light to trigger a cascade of intracellular reactions. PBM can be used to improve wound healing, and to reduce pain, inflammation, and edema. Research shows that PBM can stimulate hair growth by increasing the blood flow to the scalp and stimulating the catagen or telogen metabolism of the hair follicle. However, the effect of PBM on CIA has not been adequately investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with gynecological cancer (endometrium, cervix, ovarian or vulva) or breast cancer
- •Receiving chemotherapy ((Carbo)-Taxol)
- •Age ≥ 18 years
- •Able to comply to the study protocol
- •Able to sign written informed consent
排除标准
- •Metastatic disease
- •Pregnancy
- •Active infection of the scalp
- •Previous diagnosis of a hair loss condition
- •Interruption of chemotherapy for more than two consecutive cycles
- •Medication to stimulate hair growth (e.g., Minoxidil)
- •Severe psychological disorder or dementia.
- •Inability to speak and understand Dutch
- •Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator
- •Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
结局指标
主要结局
CTCAE-score
时间窗: One month post chemotherapy
The patient may grade their hair loss using the CTCAE criteria.
Hair loss evaluation
时间窗: One month post chemotherapy
Both the patient and a blinded study nurse will score hair regrowth based on photographs. A score of 0 equals 'total baldness' and 10 'full scalp coverage'.
Hair thickness measurement
时间窗: One month post chemotherapy
The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.
次要结局
- Quality of life score(One month post chemotherapy)
- Satisfaction score(One month post chemotherapy)