Acupuncture as the Therapeutic Modalities of Acute Toxicity in the Radiotherapy of Head and Neck Tumors
研究概览
地位
详细说明
The study will enroll 100 patients in current radiotherapy of the head and neck cancer with acute radiotoxic symptoms at least of G1. The patients will be randomized (by ticket) in two regimens 1:1.
Regimen A (control regimen): standard support treatment of adverse events of the radiotherapy.
Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture.
Due to the disease and patients differences, treatment will be individualized. Used acupuncture points will be documented. The patients difficulties will be observed and their medication and will be recorded in the patient diary.
Possible skin toxicities wil be documented by the photography.
Before the randomization, all subjects will sign the voluntary informed consent. After the achievement of 50 enrolled subjects in any regimen, the enrollment will continue only to the other regimen.
Head and neck cancer therapy will include only curative and adjuvant radiotherapy.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Brno、捷克语、65653
- 招聘中
- Masaryk Memorial Cancer Institute
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接触：
- Radana Dymáčková, MD
- 电话号码：1130 +42054313
- 邮箱：radana.dymackova@mou.cz
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Curative and adjuvant radiotherapy for head and neck tumors;
- PS 1-2;
- Patient collaboration in evaluation of the toxicity diary.
Exclusion Criteria:
- Palliative radiotherapy in the head and neck tumor;
- PS 3;
- Non-compliance of the patient.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Regimen A
Regimen A (control regimen): standard support treatment of adverse events of the radiotherapy.
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Standard supportive therapy
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实验性的：Regimen B
Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture.
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Standard supportive therapy
Schedule of the acupuncture: Acupuncture may be done ambulant or during hospitalisation . Acupuncture will be administered 1-3 times a week ( in case of severe toxicity and problems caused by the radiotherapy, it may continue also after the termination of the radiotherapy.) Acupuncture needles will be left for 5- 30 minutes, as per individual need of the patients. Acupuncture will be performed by a physician trained in acupuncture. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Management of acute toxicity of radiotherapy with acupuncture: Reducing the grade of acute toxicity in radiotherapy
大体时间：six months after the end of radiotherapy
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Reducing the grade of acute toxicity in radiotherapy.
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six months after the end of radiotherapy
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Management of chronic toxicity of radiotherapy with acupuncture: Lower incidence of chronic toxicity of radiotherapy
大体时间：six months after the end of radiotherapy
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Lower incidence of chronic toxicity of radiotherapy.
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six months after the end of radiotherapy
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合作者和调查者
出版物和有用的链接
一般刊物
- Meng Z, Garcia MK, Hu C, Chiang J, Chambers M, Rosenthal DI, Peng H, Zhang Y, Zhao Q, Zhao G, Liu L, Spelman A, Palmer JL, Wei Q, Cohen L. Randomized controlled trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma. Cancer. 2012 Jul 1;118(13):3337-44. doi: 10.1002/cncr.26550. Epub 2011 Nov 9.
- Braga FP, Lemos Junior CA, Alves FA, Migliari DA. Acupuncture for the prevention of radiation-induced xerostomia in patients with head and neck cancer. Braz Oral Res. 2011 Mar-Apr;25(2):180-5. doi: 10.1590/s1806-83242011000200014.
- Dymackova R, Kazda T, Slavik M, Selingerova I, Slampa P, Slama O. Acupuncture in the treatment of acute toxicity during and after head and neck cancer radiotherapy: Interim analysis of randomized prospective open-label trial. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2020 Dec;164(4):454-460. doi: 10.5507/bp.2020.021. Epub 2020 Jun 18.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.
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