Auricular Acupressure Improves Oxaliplatin-induced Peripheral Neuropathy and Quality of Life
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- National Cancer Institute Common Terminology Criteria for Adverse Events v5.0[NCI-CTCAE v5.0]
研究概览
简要总结
Oxaliplatin-induced peripheral neuropathy (OIPN) is a common adverse effect that becomes worse as the drug dose accumulation impacts cancer patients' daily activities and quality of life.The result of this study will determine the immediate effects of the 8-week auricular acupuncture intervention on alleviating the participants' OIPN symptoms and enhancing their quality of life. This study will continue to evaluate the carry-over effects of auricular acupuncture after the chemotherapy course ends.
详细描述
Objectives:
Oxaliplatin-induced peripheral neuropathy (OIPN) is a common adverse effect that becomes worse as the drug dose accumulation impacts cancer patients' daily activities and quality of life. This study aims to evaluate the immediate and carry-over effects of auricular acupressure on OIPN symptoms and quality of life for colorectal cancer patients.
Methods :
This randomized trial will recruit 76 participants with colorectal cancer and OIPN from the oncology outpatient department in Taiwan. The control group will receive usual care, whereas the experimental group will receive usual care in addition to auricular acupressure for 8 weeks. Outcomes will be assessed by using the chemotherapy-induced peripheral neuropathy assessment tool, neuropathic pain symptom inventory, pain visual analogue scale, and the European Organization for research and treatment of cancer-quality of life questionnaire-core 30. These assessment tools are used before the intervention, biweekly during the intervention, 2 weeks after the intervention, and one month after the end of the chemotherapy course.
Hypothesis:
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
- None
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
- •Colorectal cancer patients who are above the age of 20 years
- •Have experiencing Oxaliplatin induced peripheral neuropathy
- •Must be able to communicate
- •Willing to fill out the inform consent
排除标准
- •Symptoms of peripheral neuropathy caused by diabetes mellitus
- •Symptoms of peripheral neuropathy caused by genetic disease
- •Symptoms of peripheral neuropathy caused by spinal cord injury
- •Symptoms of peripheral neuropathy caused by alcoholism
- •With wounds on ears
- •Allergy to latex (the tapes for the auricular acupressure include latex)
结局指标
主要结局
National Cancer Institute Common Terminology Criteria for Adverse Events v5.0[NCI-CTCAE v5.0]
时间窗: This assessment tool is used at baseline, change from baseline after 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, and one month followed by completing the chemotherapy course.
For the severity of peripheral neuropathy symptoms caused by Oxaliplatin chemotherapy.
Neuropathic Pain Symptom inventory (NPSI)
时间窗: This assessment tool is used at baseline, change from baseline after 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, and one month followed by completing the chemotherapy course.
This questionnaire mainly used to assess the symptoms and severity of neuropathic pain. This questionnaire consists of four parts: 1. spontaneous and persistent pain, 2. spontaneous paroxysmal pain, and 3. Induced pain and paresthesia
Chemotherapy-induced Peripheral Neuropathy Assessment Tool(CIPNAT)
时间窗: This assessment tool is used at baseline, change from baseline after 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, and one month followed by completing the chemotherapy course.
This questionnaire is a self-assessment of the patient. It is divided into four parts: 1. The severity of symptoms; 2. The degree of trouble the symptom causes; 3. The frequency of symptoms; 4. The symptom's degree of interference in daily life.
Visual Analogue Scale (VAS)
时间窗: This assessment tool is used at baseline, change from baseline after 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, and one month followed by completing the chemotherapy course.
This study uses the Visual Analogue Scale (VAS) for pain. The patient will Self-assess the pain intensity based on their subjective feelings and current pain state.
次要结局
- European Organization for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30 version 3.0 (EORTC QLO-C30).(This assessment tool is used at baseline, change from baseline after 8 weeks, 10 weeks, and one month followed by completing the chemotherapy course.)