Randomized study exploring the combination of radiotherapy with two types of acupuncture treatment (ROSETTA): study protocol for a randomized controlled trial.
Détails
Etat: Public
Version: Final published version
ID Serval
serval:BIB_562A15302F5C
Type
Article: article d'un périodique ou d'un magazine.
Sous-type
Synthèse (review): revue aussi complète que possible des connaissances sur un sujet, rédigée à partir de l'analyse exhaustive des travaux publiés.
Collection
Publications
Institution
Titre
Randomized study exploring the combination of radiotherapy with two types of acupuncture treatment (ROSETTA): study protocol for a randomized controlled trial.
Périodique
Trials
ISSN
1745-6215 (Electronic)
ISSN-L
1745-6215
Statut éditorial
Publié
Date de publication
29/08/2017
Peer-reviewed
Oui
Volume
18
Numéro
1
Pages
398
Langue
anglais
Notes
Publication types: Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial
Publication Status: epublish
Publication Status: epublish
Résumé
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.
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.
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.
Mots-clé
Acupuncture Points, Acupuncture Therapy/adverse effects, Acupuncture Therapy/methods, Fatigue/etiology, Fatigue/psychology, Fatigue/therapy, Germany, Humans, Neoplasms/diagnosis, Neoplasms/radiotherapy, Prospective Studies, Quality of Life, Radiotherapy/adverse effects, Surveys and Questionnaires, Time Factors, Treatment Outcome, Acupuncture, Fatigue, Quality of life (QOL), Radiotherapy, Sham-controlled trial
Pubmed
Web of science
Open Access
Oui
Création de la notice
06/09/2017 14:51
Dernière modification de la notice
20/08/2019 14:10
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