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

Rebecca Asadpour, Kerstin A Kessel, Tom Bruckner, Serkan Sertel, Stephanie E Combs, Rebecca Asadpour, Kerstin A Kessel, Tom Bruckner, Serkan Sertel, Stephanie E Combs

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.

Conflict of interest statement

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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

References

    1. Levin GT, Greenwood KM, Singh F, Tsoi D, Newton RU. Exercise Improves Physical Function and Mental Health of Brain Cancer Survivors: Two Exploratory Case Studies. Integr Cancer Ther. 2016;15(2):190-6. doi:10.1177/1534735415600068. Epub 2015 Aug 14.
    1. Nilsen TS, Thorsen L, Fosså SD, Wiig M, Kirkegaard C, Skovlund E, Benestad HB, Raastad T. Effects of strength training on muscle cellular outcomes in prostate cancer patients on androgen deprivation therapy. Scand J Med Sci Sports. 2016;26(9):1026-35. doi:10.1111/sms.12543. Epub 2015 Aug 17.
    1. Enblom A, et al. Acupuncture compared with placebo acupuncture in radiotherapy-induced nausea–a randomized controlled study. Ann Oncol. 2012;23(5):1353–61. doi: 10.1093/annonc/mdr402.
    1. Enblom A, et al. The nonpenetrating telescopic sham needle may blind patients with different characteristics and experiences when treated by several therapists. Evid Based Complement Alternat Med. 2011;2011:185034. doi: 10.1155/2011/185034.
    1. Enblom A, et al. Getting the grip on nonspecific treatment effects: emesis in patients randomized to acupuncture or sham compared to patients receiving standard care. PLoS One. 2011;6(3):e14766. doi: 10.1371/journal.pone.0014766.
    1. Enblom A, et al. Pilot testing of methods for evaluation of acupuncture for emesis during radiotherapy: a randomised single subject experimental design. Acupunct Med. 2011;29(2):94–102. doi: 10.1136/aim.2010.003384.
    1. Meng Z, et al. Randomized controlled trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma. Cancer. 2012;118(13):3337–44. doi: 10.1002/cncr.26550.
    1. Meng Z, et al. Sham-controlled, randomised, feasibility trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma. Eur J Cancer. 2012;48(11):1692–9. doi: 10.1016/j.ejca.2011.12.030.
    1. Monson K, et al. Group recruitment sessions enhance patient understanding in a small multi-centre phase III clinical trial. Contemp Clin Trials. 2012;33(2):286–90. doi: 10.1016/j.cct.2011.11.003.
    1. Simcock R, et al. ARIX: a randomised trial of acupuncture v oral care sessions in patients with chronic xerostomia following treatment of head and neck cancer. Ann Oncol. 2013;24(3):776–83. doi: 10.1093/annonc/mds515.
    1. Vickers AJ. Statistical reanalysis of four recent randomized trials of acupuncture for pain using analysis of covariance. Clin J Pain. 2004;20(5):319–23. doi: 10.1097/00002508-200409000-00006.
    1. Vickers AJ, et al. Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial. BMJ. 2004;328(7442):744. doi: 10.1136/bmj.38029.421863.EB.
    1. Vickers AJ, et al. Acupuncture of chronic headache disorders in primary care: randomised controlled trial and economic analysis. Health Technol Assess. 2004;8(48):iii. doi: 10.3310/hta8480.
    1. Vickers AJ, et al. Acupuncture for postchemotherapy fatigue: a phase II study. J Clin Oncol. 2004;22(9):1731–5. doi: 10.1200/JCO.2004.04.102.
    1. Wonderling D, et al. Cost effectiveness analysis of a randomised trial of acupuncture for chronic headache in primary care. BMJ. 2004;328(7442):747. doi: 10.1136/bmj.38033.896505.EB.
    1. Endres HG, et al. [German Acupuncture Trials (gerac) address problems of methodology associated with acupuncture studies] Schmerz. 2005;19(3):201–4. doi: 10.1007/s00482-004-0345-z.
    1. Haake M, et al. German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med. 2007;167(17):1892–8. doi: 10.1001/Archinte.167.17.1892.
    1. Haake M, et al. The German multicenter, randomized, partially blinded, prospective trial of acupuncture for chronic low-back pain: a preliminary report on the rationale and design of the trial. J Altern Complement Med. 2003;9(5):763–70. doi: 10.1089/107555303322524616.
    1. Haake M, et al. Acupuncture in chronic back pain. Background, development and design of the German Acupuncture Trial (gerac-cLBP) Z Orthop Ihre Grenzgeb. 2003;141(1):6–10.
    1. Molsberger A, et al. Acupuncture in diseases of the locomotor system. Status of research and clinical applications. Orthopade. 2002;31(6):536–43. doi: 10.1007/s00132-002-0339-4.
    1. Molsberger AF, et al. Designing an acupuncture study: II. The nationwide, randomized, controlled German acupuncture trials on low-back pain and gonarthrosis. J Altern Complement Med. 2006;12(8):733–42. doi: 10.1089/acm.2006.12.733.
    1. Enblom A, et al. One third of patients with radiotherapy-induced nausea consider their antiemetic treatment insufficient. Support Care Cancer. 2009;17(1):23–32. doi: 10.1007/s00520-008-0445-x.
    1. Sertel S, et al. Acupuncture for nasal congestion: a prospective, randomized, double-blind, placebo-controlled clinical pilot study. Am J Rhinol Allergy. 2009;23(6):e23–8. doi: 10.2500/ajra.2009.23.3380.
    1. Sertel S, et al. Additional use of acupuncture to NSAID effectively reduces post-tonsillectomy pain. Eur Arch Otorhinolaryngol. 2009;266(6):919–25. doi: 10.1007/s00405-008-0851-1.
    1. Karner M, et al. Objectifying specific and nonspecific effects of acupuncture: a double-blinded randomised trial in osteoarthritis of the knee. Evid Based Complement Alternat Med. 2013;2013:427265. doi: 10.1155/2013/427265.
    1. Maimer A, et al. Objectifying acupuncture effects by lung function and numeric rating scale in patients undergoing heart surgery. Evid Based Complement Alternat Med. 2013;2013:219817. doi: 10.1155/2013/219817.
    1. Matos LC, et al. Qigong as a traditional vegetative biofeedback therapy: long-term conditioning of physiological mind-body effects. Biomed Res Int. 2015;2015:531789. doi: 10.1155/2015/531789.
    1. Pais I, et al. Effects of acupuncture on leucopenia, neutropenia, NK, and B cells in cancer patients: a randomized pilot study. Evid Based Complement Alternat Med. 2014;2014:217397. doi: 10.1155/2014/217397.
    1. Schroder S, et al. Acupuncture treatment improves nerve conduction in peripheral neuropathy. Eur J Neurol. 2007;14(3):276–81.
    1. Hauer K, et al. Stimulation of acupoint ST-34 acutely improves gait performance in geriatric patients during rehabilitation: a randomized controlled trial. Arch Phys Med Rehabil. 2011;92(1):7–14. doi: 10.1016/j.apmr.2010.09.023.
    1. Sousa CM, et al. Effects of self-administered exercises based on Tuina techniques on musculoskeletal disorders of professional orchestra musicians: a randomized controlled trial. J Integr Med. 2015;13(5):314–8. doi: 10.1016/S2095-4964(15)60194-7.
    1. Porkert M, Hempen C-H. Classical acupuncture: the standard textbook. 1995. Phainon Ed. and Media, Acta Medicinae Sinensis.
    1. Lu W, et al. Acupuncture for dysphagia after chemoradiation in head and neck cancer: rationale and design of a randomized, sham-controlled trial. Contemp Clin Trials. 2012;33(4):700–11. doi: 10.1016/j.cct.2012.02.017.
    1. Garcia MK, et al. Systematic review of acupuncture in cancer care: a synthesis of the evidence. J Clin Oncol. 2013;31(7):952–60. doi: 10.1200/JCO.2012.43.5818.
    1. Albrecht T, et al. Measurable impact of acupuncture on mucosal swelling of inferior turbinates: a prospective, randomized, controlled study. Acta Otolaryngol. 2015;135(2):169–76. doi: 10.3109/00016489.2014.973533.
    1. Enblom A, et al. Can individuals identify if needling was performed with an acupuncture needle or a non-penetrating sham needle? Complement Ther Med. 2008;16(5):288–94. doi: 10.1016/j.ctim.2008.02.012.

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi