Asadpour Rebecca, Kessel Kerstin A, Bruckner Tom, Sertel Serkan, Combs Stephanie E
Department of Radiation Oncology, Technische Universität München (TUM), Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.
Department of Radiation Sciences (DRS), Institute of Innovative Radiotherapy (iRT), Helmholtz Zentrum München, Ingolstädter Landstraße 1, 85764, Oberschleißheim, Germany.
Trials. 2017 Aug 29;18(1):398. doi: 10.1186/s13063-017-2139-5.
Adverse effects such as fatigue, pain, erythema, nausea and vomiting are commonly known in patients undergoing irradiation (RT) alone or in combination with chemotherapy (RCHT). Patients suffering from these symptoms are limited in their daily life and their quality of life (QOL) is often reduced. As addressed in several trials, acupuncture can cause amelioration of these specific disorders. Especially for pain symptoms, several groups have shown efficacy of acupuncture. To what extent the difference between traditional acupuncture (verum acupuncture) and false acupuncture (sham acupuncture) is in reducing side effects and improvement of QOL is not clear.
METHODS/DESIGN: ROSETTA is a prospective randomized phase II trial (version 1.0) to examine the efficacy of traditional acupuncture in patients with RT-related side effects. In the experimental (verum) arm (n = 37) an experienced acupuncture-trained person will treat dedicated acupuncture points. In the control (sham) arm (n = 37) sham acupuncture will be performed to provide a blinded comparison of results.
This is the first randomized prospective trial to evaluate the effect of traditional acupuncture on RT-related side effects such as fatigue and QOL.
ClinicalTrials.gov, NCT02674646 . Registered on 8 December 2015.
单独接受放疗（RT）或放疗联合化疗（RCHT）的患者中，疲劳、疼痛、红斑、恶心和呕吐等不良反应较为常见。出现这些症状的患者日常生活受到限制，生活质量（QOL）往往下降。多项试验表明，针灸可改善这些特定病症。尤其是对于疼痛症状，多个研究小组已证实针灸的有效性。传统针灸（真针灸）与假针灸（ sham针灸）在减轻副作用和改善生活质量方面的差异程度尚不清楚。
方法/设计：ROSETTA是一项前瞻性随机II期试验（版本1.0），旨在研究传统针灸对放疗相关副作用患者的疗效。在试验组（真针灸组，n = 37），由经验丰富的接受过针灸培训的人员治疗特定的穴位。在对照组（假针灸组，n = 37），将进行假针灸以对结果进行盲法比较。
这是第一项评估传统针灸对放疗相关副作用（如疲劳和生活质量）影响的随机前瞻性试验。
ClinicalTrials.gov，NCT02674646。于2015年12月8日注册。
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