Advertisement

Dysphagia

, Volume 32, Issue 2, pp 327–336 | Cite as

Impact of Compliance on Dysphagia Rehabilitation in Head and Neck Cancer Patients: Results from a Multi-center Clinical Trial

  • Gintas P. Krisciunas
  • Kerlly Castellano
  • Timothy M. McCulloch
  • Cathy L. Lazarus
  • Barbara R. Pauloski
  • Tanya K. Meyer
  • Darlene Graner
  • Douglas J. Van Daele
  • Alice K. Silbergleit
  • Lisa R. Crujido
  • Denis Rybin
  • Gheorghe Doros
  • Tamar Kotz
  • Susan E. Langmore
Original Article

Abstract

A 5-year, 16-site, randomized controlled trial enrolled 170 HNC survivors into active (estim + swallow exercise) or control (sham estim + swallowing exercise) arms. Primary analyses showed that estim did not enhance swallowing exercises. This secondary analysis determined if/how patient compliance impacted outcomes. A home program, performed 2 times/day, 6 days/week, for 12 weeks included stretches and 60 swallows paired with real or sham estim. Regular clinic visits ensured proper exercise execution, and detailed therapy checklists tracked patient compliance which was defined by mean number of sessions performed per week (0–12 times) over the 12-week intervention period. “Compliant” was defined as performing 10–12 sessions/week. Outcomes were changes in PAS, HNCI, PSS, OPSE, and hyoid excursion. ANCOVA analyses determined if outcomes differed between real/sham and compliant/noncompliant groups after 12 weeks of therapy. Of the 170 patients enrolled, 153 patients had compliance data. The mean number of sessions performed was 8.57/week (median = 10.25). Fifty-four percent of patients (n = 83) were considered “compliant.” After 12 weeks of therapy, compliant patients in the sham estim group realized significantly better PAS scores than compliant patients in the active estim group (p = 0.0074). When pooling all patients together, there were no significant differences in outcomes between compliant and non-compliant patients. The addition of estim to swallowing exercises resulted in worse swallowing outcomes than exercises alone, which was more pronounced in compliant patients. Since neither compliant nor non-compliant patients benefitted from swallowing exercises, the proper dose and/or efficacy of swallowing exercises must also be questioned in this patient population.

Keywords

Deglutition Deglutition disorders Dysphagia Compliance Head and neck cancer Estim 

Notes

Acknowledgements

We would also like to thank three companies that generously provided products needed to conduct this clinical tria: Bracco Diagnostics for donating barium, Electrodes To Go for donating electrodes, and BMR for donating estim devices. This work could not have been completed without the hard work of the following clinicians: Danielle Lodewyck, Gary Gramigna, Chris Mastriano, Kelly Gardner, Melissa Franklin, Eva Michalakis, Karen Kelly, Jodi Fritsch, Courtney Henry, Michelle Graham, Nika Khodorkovsky, Jeri Logemann, Kristin Larson, Mike Walsh, Becky Scheel, Molly Knigge, Amy Baillies, Rachael Kammer, Lisa Ehrlichster, Jackie Mojica, Barbara Messing, Lisa Valasek, Bethany Hieber, Melissa Kim, Jaclyn Shellenberger, Ginger Hamilton, Yumi Sumida, Marie Repanich, Jamie Lindholm, Cindy Grywalski, Lindsay Rigelman, Kari Krein, Steve Goldman, Susan Neese, Ashley Spreitzer, Joanna Burgess, Cynthia Wagner, Colleen Frayne, Kashaine Gray, Elaine Burke, and Maria Puglia.

Funding

This study was funded by the following National Institutes of Health, National Cancer Institute Grant: 5RO1CA120950-01A1.

Compliance with Ethical Standards

Conflict of interest

The authors report no conflict of interest.

Ethical Approval

Ethical approval to complete this research was obtained from the appropriate Internal Review Boards.

References

  1. 1.
    American Cancer Society. Cancer facts and figures 2012. Atlanta: American Cancer Society; 2012. http://www.cancer.org/Research/CancerFactsFigures/index. Accessed 6 Jan 2016.
  2. 2.
    Lazarus CL. Effects of radiation therapy and voluntary maneuvers on swallow functioning in head and neck cancer patients. Clin Commun Disord. 1993;3(4):11–20.PubMedGoogle Scholar
  3. 3.
    Smith RV, et al. Long-term swallowing problems after organ preservation therapy with concomitant radiation therapy and intravenous hydroxyurea: initial results. Arch Otolaryngol Head Neck Surg. 2000;126(3):384–9.CrossRefPubMedGoogle Scholar
  4. 4.
    Staar S, et al. Intensified hyperfractionated accelerated radiotherapy limits the additional benefit of simultaneous chemotherapy—results of a multicentric randomized German trial in advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001;50(5):1161–71.CrossRefPubMedGoogle Scholar
  5. 5.
    Marur S, et al. HPV-associated head and neck cancer: a virus-related cancer epidemic. Lancet Oncol. 2010;11(8):781–9.CrossRefPubMedPubMedCentralGoogle Scholar
  6. 6.
    Pytynia KB, Dahlstrom KR, Sturgis EM. Epidemiology of HPV-associated oropharyngeal cancer. Oral Oncol. 2014;50(5):380–6.CrossRefPubMedPubMedCentralGoogle Scholar
  7. 7.
    Hind JA, et al. Comparison of effortful and noneffortful swallows in healthy middle-aged and older adults. Arch Phys Med Rehabil. 2001;82(12):1661–5.CrossRefPubMedGoogle Scholar
  8. 8.
    Hiss SG, Huckabee ML. Timing of pharyngeal and upper esophageal sphincter pressures as a function of normal and effortful swallowing in young healthy adults. Dysphagia. 2005;20(2):149–56.CrossRefPubMedGoogle Scholar
  9. 9.
    Kahrilas PJ, et al. Volitional augmentation of upper esophageal sphincter opening during swallowing. Am J Physiol. 1991;260(3 Pt 1):G450–6.PubMedGoogle Scholar
  10. 10.
    Martin BJ, et al. Normal laryngeal valving patterns during three breath-hold maneuvers: a pilot investigation. Dysphagia. 1993;8(1):11–20.CrossRefPubMedGoogle Scholar
  11. 11.
    Lazarus C, Logemann JA, Gibbons P. Effects of maneuvers on swallowing function in a dysphagic oral cancer patient. Head Neck. 1993;15(5):419–24.CrossRefPubMedGoogle Scholar
  12. 12.
    Ohmae Y, et al. Effects of two breath-holding maneuvers on oropharyngeal swallow. Ann Otol Rhinol Laryngol. 1996;105(2):123–31.CrossRefPubMedGoogle Scholar
  13. 13.
    Freed ML, et al. Electrical stimulation for swallowing disorders caused by stroke. Respir Care. 2001;46(5):466–74.PubMedGoogle Scholar
  14. 14.
    Carnaby-Mann GD, Crary MA. Examining the evidence on neuromuscular electrical stimulation for swallowing: a meta-analysis. Arch Otolaryngol Head Neck Surg. 2007;133(6):564–71.CrossRefPubMedGoogle Scholar
  15. 15.
    Steele CM, Thrasher AT, Popovic MR. Electric stimulation approaches to the restoration and rehabilitation of swallowing: a review. Neurol Res. 2007;29(1):9–15.CrossRefPubMedGoogle Scholar
  16. 16.
    Langmore SE, et al. Efficacy of electrical stimulation and exercise for dysphagia in patients with head and neck cancer: a randomized clinical trial. Head Neck. 2016;38(Suppl 1):E1221–31.CrossRefPubMedGoogle Scholar
  17. 17.
    Rosenbek JC, et al. A penetration–aspiration scale. Dysphagia. 1996;11(2):93–8.CrossRefPubMedGoogle Scholar
  18. 18.
    Rademaker AW, et al. Oropharyngeal swallow efficiency as a representative measure of swallowing function. J Speech Lang Hear Res. 1994;37(2):314–25.CrossRefGoogle Scholar
  19. 19.
    Funk GF, et al. Comprehensive head and neck oncology health status assessment. Head Neck. 2003;25(7):561–75.CrossRefPubMedGoogle Scholar
  20. 20.
    List MA, Ritter-Sterr C, Lansky SB. A performance status scale for head and neck cancer patients. Cancer. 1990;66(3):564–9.CrossRefPubMedGoogle Scholar
  21. 21.
    Sirur R, et al. The role of theory in increasing adherence to prescribed practice. Physiother Can. 2009;61(2):68–77.CrossRefPubMedPubMedCentralGoogle Scholar
  22. 22.
    Clark AM, et al. A qualitative systematic review of influences on attendance at cardiac rehabilitation programs after referral. Am Heart J. 2012;164(6):835–845.e2.CrossRefPubMedGoogle Scholar
  23. 23.
    Melchers LJ, et al. Exercise adherence in patients with trismus due to head and neck oncology: a qualitative study into the use of the Therabite®. Int J Oral Maxillofac Surg. 2009;38(9):947–54.CrossRefPubMedGoogle Scholar
  24. 24.
    McNeely ML, et al. Predictors of adherence to an exercise program for shoulder pain and dysfunction in head and neck cancer survivors. Support Care Cancer. 2012;20(3):515–22.CrossRefPubMedGoogle Scholar
  25. 25.
    Kulbersh BD, et al. Pretreatment, preoperative swallowing exercises may improve dysphagia quality of life. Laryngoscope. 2006;116(6):883–6.CrossRefPubMedGoogle Scholar
  26. 26.
    Carnaby-Mann G, et al. Pharyngocise: randomized controlled trial of preventative exercises to maintain muscle structure and swallowing function during head-and-neck chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2012;83(1):210–9.CrossRefPubMedGoogle Scholar
  27. 27.
    Ahlberg A, et al. Early self-care rehabilitation of head and neck cancer patients. Acta Otolaryngol. 2011;131(5):552–61.CrossRefPubMedPubMedCentralGoogle Scholar
  28. 28.
    Kamstra JI, et al. TheraBite exercises to treat trismus secondary to head and neck cancer. Support Care Cancer. 2013;21(4):951–7.CrossRefPubMedGoogle Scholar
  29. 29.
    Lazarus CL, et al. Effects of exercise on swallowing and tongue strength in patients with oral and oropharyngeal cancer treated with primary radiotherapy with or without chemotherapy. Int J Oral Maxillofac Surg. 2014;43(5):523–30.CrossRefPubMedGoogle Scholar
  30. 30.
    Mortensen HR, et al. Prophylactic swallowing exercises in head and neck cancer radiotherapy. Dysphagia. 2015;30(3):304–14.CrossRefPubMedGoogle Scholar
  31. 31.
    van der Molen L, et al. A randomized preventive rehabilitation trial in advanced head and neck cancer patients treated with chemoradiotherapy: feasibility, compliance, and short-term effects. Dysphagia. 2011;26(2):155–70.CrossRefPubMedGoogle Scholar
  32. 32.
    Tang Y, et al. A randomized prospective study of rehabilitation therapy in the treatment of radiation-induced dysphagia and trismus. Strahlenther Onkol. 2011;187(1):39–44.CrossRefPubMedGoogle Scholar
  33. 33.
    Hutcheson KA, et al. Eat and exercise during radiotherapy or chemoradiotherapy for pharyngeal cancers: use it or lose it. JAMA Otolaryngol Head Neck Surg. 2013;139(11):1127–34.CrossRefPubMedPubMedCentralGoogle Scholar
  34. 34.
    Fajardo LF. The pathology of ionizing radiation as defined by morphologic patterns. Acta Oncol. 2005;44(1):13–22.CrossRefPubMedGoogle Scholar
  35. 35.
    Gramley F, et al. Atrial fibrosis and atrial fibrillation: the role of the TGF-β1 signaling pathway. Int J Cardiol. 2010;143(3):405–13.CrossRefPubMedGoogle Scholar
  36. 36.
    Johns MM, et al. Radiation fibrosis of the vocal fold: from man to mouse. Laryngoscope. 2012;122(Suppl 5):S107–25.PubMedPubMedCentralGoogle Scholar

Copyright information

© Springer Science+Business Media New York 2016

Authors and Affiliations

  • Gintas P. Krisciunas
    • 1
  • Kerlly Castellano
    • 1
  • Timothy M. McCulloch
    • 2
  • Cathy L. Lazarus
    • 3
  • Barbara R. Pauloski
    • 4
  • Tanya K. Meyer
    • 5
  • Darlene Graner
    • 6
  • Douglas J. Van Daele
    • 7
  • Alice K. Silbergleit
    • 8
  • Lisa R. Crujido
    • 9
  • Denis Rybin
    • 10
  • Gheorghe Doros
    • 10
  • Tamar Kotz
    • 11
  • Susan E. Langmore
    • 1
  1. 1.Department of OtolaryngologyBoston University Medical CenterBostonUSA
  2. 2.MadisonUSA
  3. 3.Department of OtolaryngologyMount Sinai Beth IsraelNew YorkUSA
  4. 4.Communication Sciences & DisordersUniversity of WisconsinMilwaukeeUSA
  5. 5.Department of OtolaryngologyUniversity of Washington Medical CenterSeattleUSA
  6. 6.Department of NeurologyMayo Clinic-RochesterRochesterUSA
  7. 7.Department of OtolaryngologyUniversity of IowaIowa CityUSA
  8. 8.Department of NeurologyHenry Ford HospitalDetroitUSA
  9. 9.Department of OtolaryngologyMayo Clinic-PhoenixPhoenixUSA
  10. 10.Department of BiostatisticsBoston University School of Public HealthBostonUSA
  11. 11.Department of OtolaryngologyMount Sinai HospitalNew YorkUSA

Personalised recommendations