Abstract
BackgroundAdverse 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/designROSETTA 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.DiscussionThis is the first randomized prospective trial to evaluate the effect of traditional acupuncture on RT-related side effects such as fatigue and QOL.Trial registrationClinicalTrials.gov, NCT02674646. Registered on 8 December 2015.
Highlights
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)
This is the first randomized prospective trial to evaluate the effect of traditional acupuncture on Radiation therapy (RT)-related side effects such as fatigue and quality of life (QOL)
Randomization will be performed using automated information technology (IT)-based randomization, and patients will be allocated to groups by the Study Center within the Department of Radiation Oncology, Technische Universität München (TUM)
Summary
Several studies have shown that traditional acupuncture can alleviate clinical symptoms: In Germany, especially for back pain, a multicenter study group has shown solid data in this regard and provided a strong basis for the use of acupuncture in this regard [16,17,18,19,20,21]. More trials focusing on clear questions and applying valid control arms are needed to further clarify the role of acupuncture in oncology care. To address these questions, the ROSETTA trial was set up as a prospective randomized controlled trial. Sham-acupuncture points not associated with any function in the doctrine of TCM are applied (sham acupuncture) This concept has been applied in different trials, in patients with and without cancer [3, 7, 8, 23, 24, 33, 35, 36].
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