eprintid: 23487
rev_number: 13
eprint_status: archive
userid: 1589
dir: disk0/00/02/34/87
datestamp: 2017-09-21 12:38:31
lastmod: 2021-06-15 20:45:50
status_changed: 2017-09-21 12:38:31
type: article
metadata_visibility: show
creators_name: Asadpour, Rebecca
creators_name: Kessel, Kerstin A.
creators_name: Bruckner, Tom
creators_name: Sertel, Serkan
creators_name: Combs, Stephanie E.
title: Randomized study exploring the combination of radiotherapy with two types of acupuncture treatment (ROSETTA): study protocol for a randomized controlled trial
subjects: 610
divisions: 911000
divisions: 911800
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.
date: 2017
publisher: BioMed Central
id_scheme: DOI
ppn_swb: 1656472473
own_urn: urn:nbn:de:bsz:16-heidok-234878
language: eng
bibsort: ASADPOURRERANDOMIZED2017
full_text_status: public
publication: Trials
volume: 18
number: 398
place_of_pub: London
pagerange: 1-5
issn: 1468-6694
citation:   Asadpour, Rebecca ; Kessel, Kerstin A. ; Bruckner, Tom ; Sertel, Serkan ; Combs, Stephanie E.  (2017) Randomized study exploring the combination of radiotherapy with two types of acupuncture treatment (ROSETTA): study protocol for a randomized controlled trial.  Trials, 18 (398).  pp. 1-5.  ISSN 1468-6694     
document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/23487/1/13063_2017_Article_2139.pdf