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Asadpour, R.* ; Kessel, K.A. ; Bruckner, T.* ; Sertel, S.* ; Combs, S.E.

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

Trials 18:398 (2017)

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	Open Access Gold

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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.

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Publication type Article: Journal article

Document type Scientific Article

Corresponding Author

Keywords Acupuncture ; Fatigue ; Quality Of Life (qol) ; Radiotherapy ; Sham-controlled Trial; Low-back-pain; Radiation-induced Xerostomia; Chronic Headache; Primary-care; Nasopharyngeal Carcinoma; Neck-cancer; Multicenter; Design; Prevention; Disorders

ISSN (print) / ISBN 1468-6708

e-ISSN 1745-6215

Journal Trials

Quellenangaben Volume: 18, Issue: 1, Article Number: 398

Publisher BioMed Central

Publishing Place London

Non-patent literature Publications

Reviewing status Peer reviewed

Institute(s) Institute of Radiation Medicine (IRM)