Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 2
- 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 pilot 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 pilot study 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 breast 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
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of non-invasive (stage 0) or invasive (stage 1, 2 and 3A) breast adenocarcinoma
- •Treatment with primary breast-sparing surgery (lumpectomy) and/or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal therapy
- •Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e. 25 daily fractions of 2 Gray to the whole breast followed by a boost of 8 fractions of 2 Gray to the tumor bed, 5/week)
- •Signed informed consent
排除标准
- •Previous irradiation to the same breast
- •Metastatic disease
- •Concurrent chemotherapy
- •Required use of bolus material to deliver radiotherapy (i.e. material placed on the to- be-irradiated zone to modulate the delivered dose in order the ensure an optimal distribution of the radiation dose; mostly used for treatment of superficial tumors)
研究组 & 干预措施
Treatment group
Treatment group (receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy)
干预措施: Low-level laser (Device)
Treatment group
Treatment group (receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy)
干预措施: radiotherapy (Radiation)
Control group
Control group (receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy)
干预措施: sham laser (Device)
Control group
Control group (receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy)
干预措施: radiotherapy (Radiation)
结局指标
主要结局
Radiation Dermatitis Grade
时间窗: day 54
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)
Radiation Dermatitis Assessment
时间窗: day 54
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Objective measurement of the skin hydration
时间窗: day 40
Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Objective measurement of degree of erythema of the skin
时间窗: day 54
Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Analyze the skin cytokine content of the irradiated and non-irradiated breast
时间窗: day 54
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: day 54
Tewa meter 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(day 54)
- moist desquamation(day 54)
- Pain(day 54)
- Quality of life(day 54)
研究者
Prof. dr. Jeroen Mebis
prof. dr.
Hasselt University