Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction: A Single-arm Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Skin reaction evaluation - WHO
研究概览
简要总结
Hand-foot syndrome (HFS) is a side effect of chemotherapy. HFS is characterized by redness, swelling, and pain on the palms of the hands and/or soles of the feet, which can progress to blistering. Hand-foot skin reaction (HFSR) refers to symptoms affecting the hands and/or feet associated with multikinase inhibitors (TKIs). HFS and HFSR are painful complications that can lead to compromised daily activities, sleep-wake disturbance and impaired mobility, eventually decreasing Quality of Life (QoL).
Photobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and/or near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. The aim of this study is to evaluate the effectiveness of PBMT in the management of HFS and HFSR.
详细描述
The aim of this study is to evaluate the efficacy of PBMT in the management of HFS and HFSR in patients with cancer treated with chemotherapy or TKIs up to 2 weeks post-PBMT.
Primary objective: The study seeks primarily to determine the effectiveness of PBMT in reducing the severity of HFS and HFSR in patients with cancer of different etiology undergoing chemotherapy or TKIs, diagnosed with HFS or HFSR (grade 1-3).
Secondary objective 1 : HFS/HFSR-related symptoms
A secondary aim of this study is to evaluate if PBMT and can reduce the HFS/HSFR-related symptoms during PBM treatment and up to 2 weeks post-PBMT
Secondary Objective 2: Quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with cancer of different aetiologies
- •Undergoing chemotherapy or targeted therapy (TKIs)
- •Diagnosed with HFS-HFSR grade 1, 2 or 3 (National Cancer Institute - Common Terminology Criteria for Adverse Events, NCI-CTCAE v5)
- •Age ≥ 18 years
- •Able to comply to the study protocol
- •Able to sign written informed consent
排除标准
- •Pre-existing skin rash, ulceration or open wound in the treatment area (hand, foot)
- •Known allergy to polyurethane
- •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
Skin reaction evaluation - WHO
时间窗: 2 weeks post-PBMT
The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR
Clinical photograph
时间窗: 2 weeks post-PBMT
A clinical photograph of the palm of patients' hands and sole of their feet
Skin reaction evaluation - CTCAE
时间窗: 2 weeks post-PBMT
The severity of the skin reactions will be evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5.
次要结局
- Patient subjective evaluation of skin reactions(2 weeks post-PBMT)
- Patients' satisfaction with the therapeutic intervention(Two weeks post-PBMT)
- Quality of life - DLQI(2 weeks post-PBMT)
- Quality of life - Skindex-29(2 weeks post-PBMT)