Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Radiation Dermatitis Grade
研究概览
简要总结
Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the treated area, also known as radiodermatitis (RD).
Currently, there is a wide variety of strategies to manage RD, including creams, gels, ointments, wound dressings. However, up to now, there is still no comprehensive, evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a promising, non-invasive technique for treating RD. In a recent study conducted in our research group, LLLT prevented the aggravation of RD and provided symptomatic relief in patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This was the first prospective study investigating the potential of LLLT for RD. In the current study, we want to investigate the efficacy of LLLT as a tool for the prevention of radiodermatitis in head and neck cancer patients.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of head and neck squamous cell carcinomas (HNSCC) starting in the lip, salivary gland, oral cavity (mouth), nasal cavity (inside the nose), paranasal sinuses, pharynx, or larynx
- •Scheduled for radiotherapy (>60 Gy), chemo-irradiation or bio-radiation either as primary or as post-operative treatment to the head and neck region
- •Age ≥ 18 years
- •Able to comply to the study protocol
- •Able to sign written informed consent
- •Signed written informed consent
排除标准
- •Previous irradiation to the head and/or neck region
- •Metastatic disease
- •Patients with pre-existing skin rash, ulceration or open wound in the treatment area
- •Patients with known allergic and other systemic skin diseases even when not directly affecting irradiated fields
- •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
- •Patients using high doses of non-steroidal anti-inflammatory drugs
结局指标
主要结局
Radiation Dermatitis Grade
时间窗: 3 months (during radiation therapy and one month after)
objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC)
Objective measurement of degree of erythema of the skin
时间窗: 3 months (during radiation therapy and one month after)
Mexameter MX18 will be used to objectively measure the degree of erythema of the skin
Radiation Dermatitis Assessment
时间窗: 3 months (during radiation therapy and one month after)
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Objective measurement of the skin hydration
时间窗: 3 months (during radiation therapy and one month after)
Corneometer CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Analyze the skin cytokine content of the irradiated and non-irradiated breast
时间窗: 3 months (during radiation therapy and one month after)
Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Objective measurement of trans epidermal water loss of the skin
时间窗: 3 months (during radiation therapy and one month after)
Tewameter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin
次要结局
- Satisfaction with therapy(3 months (during radiation therapy and one month after))
- Skin dex 16(3 months (during radiation therapy and one month after))
- VAS-score(3 months (during radiation therapy and one month after))
- moist desquamation(3 months (during radiation therapy and one month after))
研究者
Prof. dr. Jeroen Mebis
prof. dr.
Hasselt University