Efficacy of Traditional Chinese Medicine Patch Application at the Shenque (RN8) Acupoint in Cancer Patients Scheduled to Undergo Radiotherapy: A Study on Cancer-Related Fatigue and Heart Rate Variability
2026年7月23日 更新者：China Medical University Hospital
This randomized, double-blind, parallel-group controlled clinical trial aims to evaluate the effects of traditional Chinese medicine patch application at the Shenque (RN8) acupoint on cancer-related fatigue in adult cancer patients scheduled to undergo radiotherapy.
Eligible participants will be randomly assigned to receive either a traditional Chinese medicine patch or a sham patch at the same acupoint.
The intervention will be applied once daily for 2 hours, 7 days per week, for 2 consecutive weeks, for a total of 14 sessions.
Fatigue severity, quality of life, heart rate variability, complete blood count, and skin safety will be assessed before and after the intervention.
研究概览
研究类型
介入性
注册 (估计的)
80
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Adults aged 20 years or older.
- Patients diagnosed with cancer by a physician.
- Patients scheduled to undergo radiotherapy.
- Patients who meet the diagnostic criteria for cancer-related fatigue and have a fatigue scale score of 4 or higher.
- Patients who are willing and able to provide written informed consent after receiving an explanation of the study procedures and possible risks.
Exclusion Criteria:
- Patients who are not suitable for traditional Chinese medicine patch application, including those with wounds or skin lesions at the acupoint application site.
- Patients who are unwilling to sign the informed consent form.
- Minors, pregnant women, patients with psychiatric disorders, or vulnerable populations.
- Patients with diseases that may affect heart rate variability.
- Patients who have received astragalus polysaccharide injection within 1 month before the start of the study.
- Patients who have used Chinese herbal medicine within 1 month before the start of the study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Traditional Chinese Medicine Patch
Participants in this arm will receive traditional Chinese medicine patch application at the Shenque (RN8) acupoint once daily for 2 hours, 7 days per week, for 2 consecutive weeks, for a total of 14 sessions.
|
The traditional Chinese medicine patch will be applied at the Shenque (RN8) acupoint once daily for 2 hours, 7 days per week, for 2 consecutive weeks, for a total of 14 sessions.
The patch will be prepared by mixing 5 g of traditional Chinese medicine powder with 7 g of water and applying the mixture to gauze or a patch.
|
|
假比较器：Sham Patch
Participants in this arm will receive a sham patch at the Shenque (RN8) acupoint using the same frequency and duration as the experimental group.
The sham patch will be made with flour and caramel coloring instead of traditional Chinese medicine powder.
|
The sham patch will be applied at the Shenque (RN8) acupoint using the same frequency and duration as the experimental intervention.
The sham patch will be made with 5 g of flour and caramel coloring instead of traditional Chinese medicine powder.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change in Fatigue Severity Assessed by Visual Analog Scale From Baseline to End of Intervention
大体时间：Baseline and approximately 2 weeks
|
Baseline and approximately 2 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Quality of Life Assessed by Functional Assessment of Cancer Therapy-General From Baseline to End of Intervention
大体时间：Baseline and approximately 2 weeks
|
Quality of life will be assessed using the Functional Assessment of Cancer Therapy-General questionnaire.
The change in total score from baseline to the end of the 2-week intervention will be evaluated.
|
Baseline and approximately 2 weeks
|
|
Change in Heart Rate Variability From Baseline to End of Intervention
大体时间：Baseline and approximately 2 weeks
|
Heart rate variability will be measured using a heart rate sensor or wearable device under resting conditions.
Changes in heart rate variability parameters from baseline to the end of the 2-week intervention will be evaluated.
|
Baseline and approximately 2 weeks
|
|
Change in Complete Blood Count Parameters From Baseline to End of Intervention
大体时间：Baseline and approximately 2 weeks
|
Complete blood count parameters, including white blood cell count, hemoglobin level, and platelet count, will be measured before and after the intervention.
|
Baseline and approximately 2 weeks
|
|
Incidence of Skin Reactions at the Patch Application Site
大体时间：During the 2-week intervention
|
Skin reactions at the patch application site will be assessed using the Radiation Therapy Oncology Group skin toxicity grading scale.
The intervention will be discontinued if a skin reaction of Grade 2 or higher occurs.
|
During the 2-week intervention
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2027年7月31日
研究完成 (估计的)
2027年7月31日
研究注册日期
首次提交
2026年7月2日
首先提交符合 QC 标准的
2026年7月2日
首次发布 (实际的)
2026年7月8日
研究记录更新
最后更新发布 (实际的)
2026年7月24日
上次提交的符合 QC 标准的更新
2026年7月23日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- CMUH115-REC1-112
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.