Advertisement

Prophylactic acupuncture treatment during chemotherapy with breast cancer: a randomized pragmatic trial with a retrospective nested qualitative study

  • Benno BrinkhausEmail author
  • Barbara Kirschbaum
  • Barbara Stöckigt
  • Sylvia Binting
  • Stephanie Roll
  • Martin Carstensen
  • Claudia M. Witt
Clinical trial

Abstract

Purpose

This study investigated the effect of additional prophylactic acupuncture during chemotherapy on quality of life and side effects compared to standard treatment alone in breast cancer patients.

Methods

In a pragmatic trial, newly diagnosed breast cancer patients were randomized to additional acupuncture treatments over 6 months or standard care alone (control group). The primary outcome was the disease-specific quality of life (FACT-B). Twenty qualitative semi-structured interviews were conducted with ten patients from each group regarding their subjective experiences.

Results

A total of 150 women (mean age 51.0 (SD 10.0) years) were randomized. For the primary endpoint, FACT-B total score after 6 months, no statistically significant difference was found between groups (acupuncture: 103.5 (95%, CI 88.8 to 107.2); control (101.4 (− 97.5 to 105.4); difference 2.0 (− 3.4 to 7.5) p = 0.458)). Qualitative content analyses showed that patients in the acupuncture group described positive effects on psychological and physical well-being. For both patient groups, coping strategies were more important than reducing side effects.

Conclusions

Breast cancer patients receiving prophylactic acupuncture during chemotherapy did not show better quality of life in the questionnaires in contrast to the reported positive effects in the qualitative interviews. Coping strategies for cancer appear to be important.

Trial registration

clinicaltrials.gov; NCT01727362. Prospectively registered 11 July 2012; https://clinicaltrials.gov/ct2/show/NCT01727362. The manuscript adheres to CONSORT guidelines.

Keywords

Acupuncture Breast cancer Quality of life Complementary medicine Pragmatic trial Comparative effectiveness research 

Notes

Author contributions

All authors participated in developing the study design and protocol and in revising the manuscript. Specific tasks and responsibilities: study conventionalization and general trial coordination (CW, BB), statistical expertise and analysis (SR, SB), data management (SB), study intervention (BK), and overall medical responsibility (MC). All authors read and approved the final manuscript.

Funding

The study was kindly funded by a grant of the Dorit & Alexander Otto Foundation, Hamburg, Germany. The funder asked for a trial to explore the effectiveness of acupuncture in patients with breast cancer while receiving chemotherapy. The funder had no influence on the trial design, methodology, data analysis, or interpretation of the results.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflicts of interest.

Ethics approval

All procedures performed in the study were in accordance with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards and with the local ethics review board (Ethic Committee of Medical Association Hamburg, Reference Number PV4002; June 2012). Because guidelines for chemotherapy treatment regime changed during the study and because of the inclusion of nested qualitative study, amendments were submitted and were approved in February 2014 and June 2016, respectively.

Research involving animal rights

This article does not contain any studies with animals performed by any of the authors.

Informed consent

Informed consent was obtained from all individual participants included in the study.

References

  1. 1.
    Harbeck N, Gnant M (2017) Breast cancer. Lancet 389(10074):1134–1150.  https://doi.org/10.1016/s0140-6736(16)31891-8 CrossRefGoogle Scholar
  2. 2.
    Boon HS, Olatunde F, Zick SM (2007) Trends in complementary/alternative medicine use by breast cancer survivors: comparing survey data from 1998 and 2005. BMC Women’s Health 7:4.  https://doi.org/10.1186/1472-6874-7-4 CrossRefGoogle Scholar
  3. 3.
    Horneber M, Bueschel G, Dennert G, Less D, Ritter E, Zwahlen M (2012) How many cancer patients use complementary and alternative medicine: a systematic review and metaanalysis. Integr Cancer Ther 11(3):187–203.  https://doi.org/10.1177/1534735411423920 CrossRefGoogle Scholar
  4. 4.
    Kang E, Yang EJ, Kim SM, Chung IY, Han SA, Ku DH, Nam SJ, Yang JH, Kim SW (2012) Complementary and alternative medicine use and assessment of quality of life in Korean breast cancer patients: a descriptive study. Support Care Cancer 20(3):461–473.  https://doi.org/10.1007/s00520-011-1094-z CrossRefGoogle Scholar
  5. 5.
    Molassiotis A, Fernadez-Ortega P, Pud D, Ozden G, Scott JA, Panteli V, Margulies A, Browall M, Magri M, Selvekerova S, Madsen E, Milovics L, Bruyns I, Gudmundsdottir G, Hummerston S, Ahmad AM, Platin N, Kearney N, Patiraki E (2005) Use of complementary and alternative medicine in cancer patients: a European survey. Ann Oncol 16(4):655–663.  https://doi.org/10.1093/annonc/mdi110 CrossRefGoogle Scholar
  6. 6.
    Oskay-Ozcelik G, Lehmacher W, Konsgen D, Christ H, Kaufmann M, Lichtenegger W, Bamberg M, Wallwiener D, Overkamp F, Diedrich K, von Minckwitz G, Hoffken K, Seeber S, Mirz R, Sehouli J (2007) Breast cancer patients’ expectations in respect of the physician–patient relationship and treatment management results of a survey of 617 patients. Ann Oncol 18(3):479–484.  https://doi.org/10.1093/annonc/mdl456 CrossRefGoogle Scholar
  7. 7.
    Witt CM, Ausserer O, Baier S, Heidegger H, Icke K, Mayr O, Mitterer M, Roll S, Spizzo G, Scherer A, Thuile C, Wieser A, Schutzler L (2015) Effectiveness of an additional individualized multi-component complementary medicine treatment on health-related quality of life in breast cancer patients: a pragmatic randomized trial. Breast Cancer Res Treat 149(2):449–460.  https://doi.org/10.1007/s10549-014-3249-3 CrossRefGoogle Scholar
  8. 8.
    Dibble SL, Chapman J, Mack KA, Shih AS (2000) Acupressure for nausea: results of a pilot study. Oncol Nurs Forum 27(1):41–47Google Scholar
  9. 9.
    Shen J, Wenger N, Glaspy J, Hays RD, Albert PS, Choi C, Shekelle PG (2000) Electroacupuncture for control of myeloablative chemotherapy-induced emesis: a randomized controlled trial. JAMA 284(21):2755–2761CrossRefGoogle Scholar
  10. 10.
    Molassiotis A, Sylt P, Diggins H (2007) The management of cancer-related fatigue after chemotherapy with acupuncture and acupressure: a randomised controlled trial. Complement Ther Med 15(4):228–237.  https://doi.org/10.1016/j.ctim.2006.09.009 CrossRefGoogle Scholar
  11. 11.
    Vickers AJ, Straus DJ, Fearon B, Cassileth BR (2004) Acupuncture for postchemotherapy fatigue: a phase II study. J Clin Oncol 22(9):1731–1735.  https://doi.org/10.1200/jco.2004.04.102 CrossRefGoogle Scholar
  12. 12.
    Crew KD, Capodice JL, Greenlee H, Apollo A, Jacobson JS, Raptis G, Blozie K, Sierra A, Hershman DL (2007) Pilot study of acupuncture for the treatment of joint symptoms related to adjuvant aromatase inhibitor therapy in postmenopausal breast cancer patients. J Cancer Survivorship 1(4):283–291.  https://doi.org/10.1007/s11764-007-0034-x CrossRefGoogle Scholar
  13. 13.
    Mao JJ, Bruner DW, Stricker C, Farrar JT, Xie SX, Bowman MA, Pucci D, Han X, DeMichele A (2009) Feasibility trial of electroacupuncture for aromatase inhibitor-related arthralgia in breast cancer survivors. Integr Cancer Ther 8(2):123–129.  https://doi.org/10.1177/1534735409332903 CrossRefGoogle Scholar
  14. 14.
    Deng G, Vickers A, Yeung S, D’Andrea GM, Xiao H, Heerdt AS, Sugarman S, Troso-Sandoval T, Seidman AD, Hudis CA, Cassileth B (2007) Randomized, controlled trial of acupuncture for the treatment of hot flashes in breast cancer patients. J Clin Oncol 25(35):5584–5590.  https://doi.org/10.1200/jco.2007.12.0774 CrossRefGoogle Scholar
  15. 15.
    Hervik J, Mjaland O (2009) Acupuncture for the treatment of hot flashes in breast cancer patients, a randomized, controlled trial. Breast Cancer Res Treat 116(2):311–316.  https://doi.org/10.1007/s10549-008-0210-3 CrossRefGoogle Scholar
  16. 16.
    Walker EM, Rodriguez AI, Kohn B, Ball RM, Pegg J, Pocock JR, Nunez R, Peterson E, Jakary S, Levine RA (2010) Acupuncture versus venlafaxine for the management of vasomotor symptoms in patients with hormone receptor-positive breast cancer: a randomized controlled trial. J Clin Oncol 28(4):634–640.  https://doi.org/10.1200/jco.2009.23.5150 CrossRefGoogle Scholar
  17. 17.
    Bao T, Iris Zhi W, Vertosick EA, Li QS, DeRito J, Vickers A, Cassileth BR, Mao JJ, Van Zee KJ (2018) Acupuncture for breast cancer-related lymphedema: a randomized controlled trial. Breast Cancer Res Treat 170(1):77–87.  https://doi.org/10.1007/s10549-018-4743-9 CrossRefGoogle Scholar
  18. 18.
    Hershman DL, Unger JM, Greenlee H, Capodice JL, Lew DL, Darke AK, Kengla AT, Melnik MK, Jorgensen CW, Kreisle WH, Minasian LM, Fisch MJ, Henry NL, Crew KD (2018) Effect of acupuncture vs sham acupuncture or waitlist control on joint pain related to aromatase inhibitors among women with early-stage breast cancer: a randomized clinical trial. JAMA 320(2):167–176.  https://doi.org/10.1001/jama.2018.8907 CrossRefGoogle Scholar
  19. 19.
    Ezzo JM, Richardson MA, Vickers A, Allen C, Dibble SL, Issell BF, Lao L, Pearl M, Ramirez G, Roscoe J, Shen J, Shivnan JC, Streitberger K, Treish I, Zhang G (2006) Acupuncture-point stimulation for chemotherapy-induced nausea or vomiting. Cochrane Database Syst Rev.  https://doi.org/10.1002/14651858.cd002285.pub2 Google Scholar
  20. 20.
    Vickers A (2004) Alternative cancer cures: “unproven” or “disproven”? CA 54(2):110–118Google Scholar
  21. 21.
    O’Regan D, Filshie J (2010) Acupuncture and cancer. Auton Neurosci 157(1–2):96–100.  https://doi.org/10.1016/j.autneu.2010.05.001 CrossRefGoogle Scholar
  22. 22.
    Chao LF, Zhang AL, Liu HE, Cheng MH, Lam HB, Lo SK (2009) The efficacy of acupoint stimulation for the management of therapy-related adverse events in patients with breast cancer: a systematic review. Breast Cancer Res Treat 118(2):255–267.  https://doi.org/10.1007/s10549-009-0533-8 CrossRefGoogle Scholar
  23. 23.
    Witt CM, Cardoso MJ (2016) Complementary and integrative medicine for breast cancer patients—evidence based practical recommendations. Breast 28:37–44.  https://doi.org/10.1016/j.breast.2016.04.012 CrossRefGoogle Scholar
  24. 24.
    Greenlee H, DuPont-Reyes MJ, Balneaves LG, Carlson LE, Cohen MR, Deng G, Johnson JA, Mumber M, Seely D, Zick SM, Boyce LM, Tripathy D (2017) Clinical practice guidelines on the evidence-based use of integrative therapies during and after breast cancer treatment. CA 67(3):194–232.  https://doi.org/10.3322/caac.21397 Google Scholar
  25. 25.
    Arbeitsgemeinschaft Gynäkologische Onkologie e.V. (2016) Diagnosis and Treatment of Patients with Primary and Metastatic Breast Cancer. https://www.ago-online.de/en/guidelines-mamma/march-2016/. Guidelines Breast Version 2016.1
  26. 26.
    MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D (2010) Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med 7(6):e1000261.  https://doi.org/10.1371/journal.pmed.1000261 CrossRefGoogle Scholar
  27. 27.
    Office des Leitlinienprogrammes Onkologie, Deutsche Krebsgesellschaft e.V., S3-Leitlinie Diagnostik, Therapie und Nachsorge des Mammakarzinoms (Version 4.0, 2017) http://www.leitlinienprogramm-onkologie.de/leitlinien/mammakarzinom/
  28. 28.
    Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G (1997) Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol 15(3):974–986CrossRefGoogle Scholar
  29. 29.
    Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E (1997) Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain SymptomManage 13(2):63–74CrossRefGoogle Scholar
  30. 30.
    Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J (1993) The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol 11(3):570–579CrossRefGoogle Scholar
  31. 31.
    Bullinger M, Kirchberger I (1998) SF-36 Fragebogen zum Gesundheitszustand. Hogrefe, GöttingenGoogle Scholar
  32. 32.
    Bullinger M, Kirchberger I, Ware J (1995) Der deutsche SF-36 Health Survey Übersetzung und psychometrische Testung eines krankheitsbergreifenden Instruments zur Erfassung der gesundheitsbezogenen Lebensqualität. Zeitschrift für Gesundheitswissenschaften 3(1):21–36Google Scholar
  33. 33.
    National Cancer Institute - Division of Cancer Treatment & Diagnosis (2014) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm. Accessed Oct 2017
  34. 34.
    Hsieh HF, Shannon SE (2005) Three approaches to qualitative content analysis. Qual Health Res 15(9):1277–1288.  https://doi.org/10.1177/1049732305276687 CrossRefGoogle Scholar
  35. 35.
    Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D (2008) Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 337:a2390CrossRefGoogle Scholar
  36. 36.
    Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Spiegel G, Barakat R, Pearl ML, Sharma SK (2009) Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol 27(32):5331–5336.  https://doi.org/10.1200/jco.2009.22.3248 CrossRefGoogle Scholar
  37. 37.
    Garcia MK, McQuade J, Haddad R, Patel S, Lee R, Yang P, Palmer JL, Cohen L (2013) Systematic review of acupuncture in cancer care: a synthesis of the evidence. J Clin Oncol 31(7):952–960.  https://doi.org/10.1200/jco.2012.43.5818 CrossRefGoogle Scholar
  38. 38.
    Ezzo J, Vickers A, Richardson MA, Allen C, Dibble SL, Issell B, Lao L, Pearl M, Ramirez G, Roscoe JA, Shen J, Shivnan J, Streitberger K, Treish I, Zhang G (2005) Acupuncture-point stimulation for chemotherapy-induced nausea and vomiting. J Clin Oncol 23(28):7188–7198.  https://doi.org/10.1200/jco.2005.06.028 CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Charité – Universitätsmedizin Berlin, corporatemember of Freie Universität Berlin, Humboldt-Universität zuBerlin, and Berlin Institute of Health, Institute for Social MedicineEpidemiology and Health EconomicsBerlinGermany
  2. 2.Jerusualem HospitalHamburgGermany
  3. 3.Institute for Complementary and Integrative MedicineUniversity Hospital Zurich and University of ZurichZurichSwitzerland

Personalised recommendations