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

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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.

Electronic supplementary material

The online version of this article (doi:10.1186/s13063-017-2139-5) contains supplementary material, which is available to authorized users.

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Most cited references 30

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Systematic review of acupuncture in cancer care: a synthesis of the evidence.

Richard Philip Lee, Peiying Yang, M Falcon … (2013)

Many cancer centers offer acupuncture services. To date, a comprehensive systematic review of acupuncture in cancer care has not been conducted. The purpose of this review was to evaluate the efficacy of acupuncture for symptom management in patients with cancer. Medline, Embase, CINAHL, Cochrane (all databases), Scopus, and PubMed were searched from inception through December 2011 for prospective randomized clinical trials (RCT) evaluating acupuncture for symptom management in cancer care. Only studies involving needle insertion into acupuncture points were included. No language limitations were applied. Studies were assessed for risk of bias (ROB) according to Cochrane criteria. Outcomes by symptom were designated as positive, negative, or unclear. A total of 2,151 publications were screened. Of those, 41 RCTs involving eight symptoms (pain, nausea, hot flashes, fatigue, radiation-induced xerostomia, prolonged postoperative ileus, anxiety/mood disorders, and sleep disturbance) met all inclusion criteria. One positive trial of acupuncture for chemotherapy-induced nausea and vomiting had low ROB. Of the remaining studies, eight had unclear ROB (four positive, three negative, and one with unclear outcomes). Thirty-three studies had high ROB (19 positive, 11 negative, and three with both positive and negative outcomes depending on the symptom). Acupuncture is an appropriate adjunctive treatment for chemotherapy-induced nausea/vomiting, but additional studies are needed. For other symptoms, efficacy remains undetermined owing to high ROB among studies. Future research should focus on standardizing comparison groups and treatment methods, be at least single-blinded, assess biologic mechanisms, have adequate statistical power, and involve multiple acupuncturists.

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Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial.

Adrian Smith, Peter Fisher, Nadia Ellis … (2004)

To determine the effects of a policy of "use acupuncture" on headache, health status, days off sick, and use of resources in patients with chronic headache compared with a policy of "avoid acupuncture." Randomised, controlled trial. General practices in England and Wales. 401 patients with chronic headache, predominantly migraine. Interventions Patients were randomly allocated to receive up to 12 acupuncture treatments over three months or to a control intervention offering usual care. Headache score, SF-36 health status, and use of medication were assessed at baseline, three, and 12 months. Use of resources was assessed every three months. Headache score at 12 months, the primary end point, was lower in the acupuncture group (16.2, SD 13.7, n = 161, 34% reduction from baseline) than in controls (22.3, SD 17.0, n = 140, 16% reduction from baseline). The adjusted difference between means is 4.6 (95% confidence interval 2.2 to 7.0; P = 0.0002). This result is robust to sensitivity analysis incorporating imputation for missing data. Patients in the acupuncture group experienced the equivalent of 22 fewer days of headache per year (8 to 38). SF-36 data favoured acupuncture, although differences reached significance only for physical role functioning, energy, and change in health. Compared with controls, patients randomised to acupuncture used 15% less medication (P = 0.02), made 25% fewer visits to general practitioners (P = 0.10), and took 15% fewer days off sick (P = 0.2). Acupuncture leads to persisting, clinically relevant benefits for primary care patients with chronic headache, particularly migraine. Expansion of NHS acupuncture services should be considered.

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Cost effectiveness analysis of a randomised trial of acupuncture for chronic headache in primary care.

David Wonderling, Rob McCarney, Richard Grieve … (2004)

To evaluate the cost effectiveness of acupuncture in the management of chronic headache. Cost effectiveness analysis of a randomised controlled trial. General practices in England and Wales. 401 patients with chronic headache, predominantly migraine. Interventions Patients were randomly allocated to receive up to 12 acupuncture treatments over three months from appropriately trained physiotherapists, or to usual care alone. Incremental cost per quality adjusted life year (QALY) gained. Total costs during the one year period of the study were on average higher for the acupuncture group (403 pounds sterling; 768 dollars; 598 euros) than for controls (217 pounds sterling) because of the acupuncture practitioners' costs. The mean health gain from acupuncture during the one year of the trial was 0.021 quality adjusted life years (QALYs), leading to a base case estimate of 9180 pounds sterling per QALY gained. This result was robust to sensitivity analysis. Cost per QALY dropped substantially when the analysis incorporated likely QALY differences for the years after the trial. Acupuncture for chronic headache improves health related quality of life at a small additional cost; it is relatively cost effective compared with a number of other interventions provided by the NHS.

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Author and article information

Contributors

Rebecca Asadpour: rebecca.asadpour@gmx.de

Kerstin A. Kessel: kerstin.kessel@tum.de

Tom Bruckner: Tom.bruckner@imbi.med.uni-heidelberg.de

Serkan Sertel: praxis@prof-sertel.de

Stephanie E. Combs: +49-89-4140-4501 , stephanie.combs@tum.de

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 29 August 2017

Publication date PMC-release: 29 August 2017

Publication date Collection: 2017

Volume: 18

Electronic Location Identifier: 398

Affiliations

[1 ]Department of Radiation Oncology, Technische Universität München (TUM), Klinikum rechts der Isar, Ismaninger Straße 22, 81675 Munich, Germany

[2 ]ISNI 0000 0004 0483 2525, GRID grid.4567.0, Department of Radiation Sciences (DRS), , Institute of Innovative Radiotherapy (iRT), Helmholtz Zentrum München, ; Ingolstädter Landstraße 1, 85764 Oberschleißheim, Germany

[3 ]ISNI 0000 0001 2190 4373, GRID grid.7700.0, Department of Medical Biometry, , Institute of Medical Biometry and Informatics (IMBI), Universität Heidelberg, ; Im Neuenheimer Feld 305, 69120 Heidelberg, Germany

[4 ]Praxisgemeinschaft Prof. Sertel & Dr. Passerino , Rottstrasse 39, 67061 Ludwigshafen am Rhein, Germany

[5 ]Deutsches Konsortium für Translationale Krebsforschung (DKTK), Partner Site Munich, Munich, Germany

[6 ]ISNI 0000 0001 2190 4373, GRID grid.7700.0, Department of Otorhinolaryngology, Head & Neck Surgery, , University of Heidelberg, ; Im Neuenheimer Feld 400, 69120 Heidelberg, Germany

[7 ]ISNI 0000 0001 0423 4662, GRID grid.8515.9, Department of 325 Otorhinolaryngology, Head and Neck Surgery, , University Hospital CHUV, 326 Bâtiment hospitalier, ; Rue du Bugnon 46, 1011, Lausanne, Switzerland

Article

Publisher ID: 2139

DOI: 10.1186/s13063-017-2139-5

PMC ID: 5575840

SO-VID: 45ed57f6-5133-4595-bfba-b6dd9215fffc

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 21 November 2016

Date accepted : 3 August 2017

Funding

Funded by: RHCCC - Cancer Center MUNICH

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: acupuncture,radiotherapy,fatigue,quality of life (qol),sham-controlled trial

Data availability:

ScienceOpen disciplines: Medicine

Keywords: acupuncture, radiotherapy, fatigue, quality of life (qol), sham-controlled trial

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

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Abstract

Background

Methods/design

Discussion

Trial registration

Electronic supplementary material

Related collections

Asian Journal of Quality of Life (AjQoL)

Most cited references 30

Systematic review of acupuncture in cancer care: a synthesis of the evidence.

Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial.

Cost effectiveness analysis of a randomised trial of acupuncture for chronic headache in primary care.

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