Photobiomodulation Therapy for the Management of Chemotherapy-induced Alopecia: a Randomized, Placebo-controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- visual analogue scale (VAS)
研究概览
简要总结
Chemotherapy (CT) remains an important treatment modality for breast cancer patients. Unfortunately, this systemic treatment comes with many quality of life impairing complications. Chemotherapy-induced alopecia (CIA) occurs in about 65% of the patients. Hair loss due to CT is reversible, but hair regrowth requires several months to a year after CT. Currently, the only available preventive measure is based on scalp cooling. Nevertheless, this treatment has a highly variable success rate and it brings along several side effects. Photobiomodulation therapy (PBMT) is a new, preventive and therapeutic technique in the supportive care of cancer patients. It uses visible and (near)- infrared light produced by laser diodes or light-emitting diodes (LED) at a low power to stimulate tissue repair and reduce inflammation and pain. The investigator's research team demonstrated already that PBMT can prevent oral mucositis and acute radiodermatitis. The aim of this project is to explore the use of PBMT in the management of CIA. Results of this project will lead to an improvement of the patients' quality of life after CT.
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
- Single (Participant)
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
- •Informed Consent as documented by signature.
- •Age 18 years or above
- •Use of a wig for at least 2 hours a day
- •Able to read and converse in Dutch
- •Skin type I to IV on the Fitzpatrick Skin Type Scale
- •Diagnosis of non-invasive (stage 0) or invasive (stage 1, 2 and 3A) breast adenocarcinoma.
- •Treatment with neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy: anthracycline and taxane containing (paclitaxel or docetaxel) chemotherapy regimen.
- •Diagnosed with CIA grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE)
- •Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis).
排除标准
- •Metastatic disease
- •Severe or unstable cardio- respiratory or musculoskeletal disease
- •Pregnancy
- •Presence of cognitive impairment that might impact study outcomes
- •Previously (before start of chemotherapy) diagnosed with a hair loss condition
- •Receiving scalp cooling during chemotherapy
- •Active infection on the scalp
- •Chronic dermatologic condition (e.g. eczema, psoriasis, infection)
- •Take any of the following medications for 6 months prior to initiation of the study: minoxidil, finasteride (or any other 5α-reductase inhibitor medications), medications with anti-androgenic properties (e.g. cyproterone, spironolactone, ketoconazole, flutamide and bicalutamide)n medications that can potentially cause hypertrichosis (ciclosporin, diazoxide, phenytoin and psoralens), and oral glucocorticoids
结局指标
主要结局
visual analogue scale (VAS)
时间窗: Month 3
A mechanical visual analogue scale (VAS) will be used to evaluate the patients' hair regrowth based on photographs taken at the four time points. The patients will be asked to indicate their subjective experience of hair regrowth. This score is associated with a certain score, in which 0 = 'total baldness' and 10 = 'full scalp coverage'.
次要结局
- EORTC QLQ-C30 Quality of life questionnaire(Month 3)
- QLQ-BR23 Quality of life questionnaire(Month 3)
- Patient global satisfaction numerical rating scale(Month 3)
研究者
Prof. dr. Jeroen Mebis
Principal Investigator
Hasselt University