The Efficacy of Acupuncture and Laser Acupuncture in Treating Chemotherapy or Target Therapy-induced Hand-foot Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- The change of LF/HF before and after treatment
研究概览
简要总结
Chemotherapy or target therapy-induced hand-foot syndrome in cancer patients affects the quality of life. At present, there is no better treatment for this side effect of chemotherapy or target therapy. In severe cases, it is necessary to reduce the dose of chemotherapy or target therapy, which may affect the progress and effect of chemotherapy. In recent years, acupuncture has been widely used for many side effects of chemotherapy, such as numbness of hands and feet, gastrointestinal discomfort, and dizziness. There have been many studies have proved to be effective, but quite few studies explored the acupuncture treatment improves the hand-foot syndrome caused by chemotherapy or target therapy in cancer patients. Therefore, the investigators expect to evaluate the efficacy of acupuncture, and applying acupuncture or laser acupuncture to improve hand-foot syndrome caused by chemotherapy or target therapy in cancer patients in the future.
详细描述
The investigators design a single-center, sham-controlled, assessor- and subject- blind, randomized clinical trial. 60 subjects will be equally and randomly divided into an acupuncture group, laser acupuncture, and sham-laser acupuncture groups in the 6-week trial. Each subject receives acupuncture, laser acupuncture, or sham-laser acupuncture three times a week for three consecutive weeks depending on their group, with a total of 9 times interventions. Outcome measures include Common adverse events evaluation standard version 5.0 (CTCAE) and Visual Analogue Scale (VAS), Dermatology Life Quality Index (DLQI) and assessment of cancer patients' quality of life questionnaire (EORTC QLQ-C30). ANSWatch and Thermal Image Camera are also used to assess those subjects. Those outcome measures will be conducted at baseline, the 3rd and the 6th week after the interventions.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer patients receiving chemotherapy or targeted therapy
- •Age over 20 years old
- •Western medicine diagnoses hand-foot syndrome
- •Sign the consent form
排除标准
- •Pregnant or planning to become pregnant
- •Serious arrhythmia (or cardiac pacemaker installed)
- •Severe organ failure, such as heart and lung failure, liver and kidney failure
- •Psychiatric history, unable to cooperate with acupuncture and assessors
- •Those who received traditional Chinese medicine treatment for hand-foot skin reaction
结局指标
主要结局
The change of LF/HF before and after treatment
时间窗: Change from Baseline LF/HF at 3 weeks
testing LF/HF assessed by ANSWatch wrist monitor
The change of temperature of limbs before and after treatment
时间窗: Change from Baseline temperature at 3 weeks
testing temperature assessed by Thermal Imaging Analysis
The change of Common Terminology Criteria for Adverse Events (CTCAE) version 5. 0
时间窗: Change from Baseline severity of hand-foot syndrome at 3 weeks
Evaluate skin symptoms assessed by Common Terminology Criteria for Adverse Events version 5. 0 (total three grade. Grade 1 is minimal skin changes, and grade 3 is severe skin changes)
The change of scores of Visual analogue scale (VAS)
时间窗: Change from Baseline severity of pain at 3 weeks
pain evaluation assessed by Visual analogue scale, score from 0 (no pain) to 10 (unbearable pain)
The change of Dermatology Life Quality Index (questionnaire)
时间窗: Change from Baseline quality of life at 3 weeks
evaluate quality of life assessed by Dermatology Life Quality Index
The change of EORTC QLQ-C30 (questionnaire)
时间窗: Change from Baseline quality of life at 3 weeks
evaluate quality of life assessed by EORTC QLQ-C30
次要结局
- The change of temperature of limbs before and after treatment(Change from Baseline temperature at 6 weeks)
- The change of EORTC QLQ-C30 (questionnaire)(Change from Baseline quality of life at 6 weeks)
- The change of Common Terminology Criteria for Adverse Events (CTCAE) version 5. 0(Change from Baseline severity of hand-foot syndrome at 6 weeks)
- The change of Dermatology Life Quality Index (questionnaire)(Change from Baseline quality of life at 6 weeks)
- The change of scores of Visual analogue scale (VAS)(Change from Baseline severity of pain at 6 weeks)
- The change of LF/HF before and after treatment(Change from Baseline LF/HF at 6 weeks)
研究者
Yu-Chen Lee
Chief and Attending Physician
China Medical University Hospital