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Clinical Trial
. 2017 Aug 29;18(1):398.
doi: 10.1186/s13063-017-2139-5.

Randomized study exploring the combination of radiotherapy with two types of acupuncture treatment (ROSETTA): study protocol for a randomized controlled trial

Rebecca Asadpour  1 , Kerstin A Kessel  1   2 , Tom Bruckner  3 , Serkan Sertel  4   5   6 , Stephanie E Combs  7   8   9
Affiliations
Clinical Trial

Randomized study exploring the combination of radiotherapy with two types of acupuncture treatment (ROSETTA): study protocol for a randomized controlled trial

Rebecca Asadpour et al. Trials. .

Abstract

Background: 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.

Discussion: This is the first randomized prospective trial to evaluate the effect of traditional acupuncture on RT-related side effects such as fatigue and QOL.

Trial registration: ClinicalTrials.gov, NCT02674646 . Registered on 8 December 2015.

Keywords: Acupuncture; Fatigue; Quality of life (QOL); Radiotherapy; Sham-controlled trial.

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Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1
Fig. 1
Schedule of enrolment, interventions and assessments in the ROSETTA trial. EORTC European Organization for Research and Treatment of Cancer, QOL quality of life, TCM Traditional Chinese Medicine
See this image and copyright information in PMC

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