Ben-Arie Eyal, Kao Pei-Yu, Ho Wen-Chao, Lee Yu Chen
Graduate Institute of Acupuncture Science (Collage of Chinese Medicine) China Medical University.
Division of Thoracic Surgery, Department of Surgery.
Medicine (Baltimore). 2019 Aug;98(35):e16944. doi: 10.1097/MD.0000000000016944.
Head and neck cancer patients are at a high risk to suffer from malnourishment, a risk that increases in postoperative condition and with the use of enteral nutrition (EN). Until now patients who are suffering from indigestion in the intensive care unit (ICU) received treatment in the form of prokinetic drugs, drugs that can lead to serious side effects and only can partially improve digestion functions. Acupuncture was used successfully in several clinical trials to improve postoperative indigestion in cancer patients without any reported adverse events. The study aims are to investigate acupuncture effect in combination with prokinetic drugs in the treatment of indigestion in postoperative oral and hypopharyngeal cancer patients in the ICU.
Single-center, double-blind randomized control trial will compare between 2 equal groups. A total of 28 patients that will meet the inclusion criteria: age 30 to 80, postplastic surgery for oral cancer or hypopharyngeal cancer, developed feeding intolerance 2 times in the first postoperative day, Apache score <20, and needed EN. Patients will be randomly divided (1:1) into treatment group or control group for 3 treatments in 3 days along with routine ICU treatment. The main outcome measurement will be the number of days a patient needs to reach his total energy expenditure.
The results will shed light on the effectiveness and safety of acupuncture in a double-blind design treating postoperative ICU cancer patients. In addition, the study presents a revolutionary double-blind design that if, will prove as successful might influence the way double-blind acupuncture studies are performed today.
The study will be conducted in the surgical ICU department, of China medical university hospital, Taichung 404, Taiwan. The study is conducted on stable ICU patients and is anticipated to have minimum risk for adverse events. Patients enrollment and data collection will start from May 15, 2019. The study expected completion time: June 2021.
头颈癌患者营养不良风险很高，术后以及使用肠内营养（EN）时这种风险会增加。到目前为止，重症监护病房（ICU）中消化不良的患者接受促动力药物治疗，这类药物会导致严重副作用，且只能部分改善消化功能。在多项临床试验中，针灸已成功用于改善癌症患者术后消化不良，且未报告任何不良事件。本研究旨在探讨针灸联合促动力药物治疗ICU中口腔和下咽癌术后患者消化不良的效果。
单中心、双盲随机对照试验将比较两个相等的组。共有28名符合纳入标准的患者：年龄30至80岁，接受口腔癌或下咽癌整形手术后，术后第一天出现2次喂养不耐受，急性生理与慢性健康状况评分系统（Apache）评分<20，且需要肠内营养。患者将被随机（1:1）分为治疗组或对照组，在3天内进行3次治疗，并接受常规ICU治疗。主要结局指标将是患者达到其总能量消耗所需的天数。
结果将揭示双盲设计下针灸治疗术后ICU癌症患者的有效性和安全性。此外，该研究提出了一种革命性的双盲设计，如果证明成功，可能会影响当今双盲针灸研究的开展方式。
该研究将在中国台湾台中市中国医药大学附设医院外科ICU进行。该研究针对病情稳定的ICU患者开展，预计不良事件风险最小。患者招募和数据收集将于2019年5月15日开始。研究预计完成时间：2021年6月。
