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Xerostomia health-related quality of life: NRG oncology RTOG 0537

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Abstract

Purpose

The purpose of this secondary analysis was to determine change in overall health-related quality of life (HRQOL) based on patient data obtained from NRG Oncology RTOG 0537 as measured by the RTOG-modified University of Washington Head and Neck Symptom Score (RM-UWHNSS).

Methods

A multi-site prospective randomized clinical trial design stratified 137 patients with post-radiation therapy xerostomia according to prior pilocarpine (PC) treatment and time after radiation therapy and/or chemotherapy and randomized patients into two groups. Patients were assigned to acupuncture or PC. Twenty-four sessions of acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) were administered over 12 weeks, or oral PC (5 mg) three times daily over the same 12 weeks. The RM-UWHNSS was administered at baseline and at 4, 6, 9, and 15 months after the date of randomization.

Results

There were no between-arm differences in change scores on the RM-UWHNSS in the individual items, total score, or factor scores. For statistical modeling, race and time were significant for all outcomes (total and factor scores), while treatment arm was not significant. The ALTENS arm showed greater yet nonsignificant improvement in outcomes compared to the PC arm.

Conclusion

Although no significant treatment differences were seen in this trial, patients receiving ALTENS consistently had lower scores, indicating better function, as compared to those receiving PC. Radiation-induced xerostomia improved over time for all patients.

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Acknowledgments

This project was supported by Grants U10CA21661 (RTOG-Ops-Stat), U10CA180868 (NRG Oncology Operations), U10CA180822 (NRG Oncology SDMC), U10CA37422 (CCOP), UG1CA189867 (NCORP) from the National Cancer Institute (NCI).

Author’s contribution

Drs. Wyatt, Pugh, Wong, Sagar, Yom, and Berk were involved in conception and design. Drs. Wong, Sagar, Singh, Koyfman, Nguyen-Tân, Yom, Cardinale, Sultanem, Hodson, Krempl, Yeh, Berk, and Ms. Lukaszczyk acquired the data. Drs. Wyatt, Pugh, Wong, Sagar, Yom, and Berk analyzed and interpreted the data. Drs. Wyatt, Pugh, Wong, Sagar, Singh, Koyfman, Nguyen-Tân, Yom, Cardinale, Sultanem, Hodson, Krempl, Yeh, Berk, and Ms. Lukaszczyk drafted and revised the manuscript. Drs. Wyatt, Pugh, Wong, Sagar, Singh, Koyfman, Nguyen-Tân, Yom, Cardinale, Sultanem, Hodson, Krempl, Yeh, Berk, and Ms. Lukaszczyk approved the final version of the manuscript. All authors agree to be accountable for all aspects of the work.

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Authors and Affiliations

  1. College of Nursing, Michigan State University, 1355 Bogue St. Room C345, East Lansing, MI, 48824, USA

    Gwen Wyatt

  2. NRG Oncology Statistics and Data Management Center, Philadelphia, PA, USA

    Stephanie L. Pugh

  3. Juravinski Cancer Centre, Hamilton, ON, Canada

    Raimond K. W. Wong, Stephen Sagar & Ian Hodson

  4. Roswell Park Cancer Institute, Buffalo, NY, USA

    Anurag K. Singh MD

  5. Cleveland Clinic, Cleveland, OH, USA

    Shlomo A. Koyfman

  6. Centre Hospitalier de l’Université de Montréal-Hôpital Notre-Dame, Montreal, QC, Canada

    Phuc F. Nguyen-Tân

  7. University of California San Francisco, San Francisco, CA, USA

    Sue S. Yom

  8. Yale-New Haven Hospital Saint Raphael Campus, New Haven, CT, USA

    Francis S. Cardinale

  9. McGill University, Montreal, QC, Canada

    Khalil Sultanem

  10. University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA

    Greg A. Krempl

  11. John H. Stroger, Jr. Hospital of Cook County MB-CCOP, Chicago, IL, USA

    Barbara Lukaszczyk

  12. Indiana University Hospital/Melvin and Bren Simon Cancer Center, Indianapolis, IN, USA

    Alexander M. Yeh

  13. University of South Florida H. Lee Moffitt Cancer Center, Tampa, FL, USA

    Lawrence Berk

Authors
  1. Gwen Wyatt
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  2. Stephanie L. Pugh
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  3. Raimond K. W. Wong
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  4. Stephen Sagar
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  5. Anurag K. Singh MD
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  6. Shlomo A. Koyfman
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  7. Phuc F. Nguyen-Tân
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  8. Sue S. Yom
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  9. Francis S. Cardinale
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  10. Khalil Sultanem
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  11. Ian Hodson
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  12. Greg A. Krempl
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  13. Barbara Lukaszczyk
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  14. Alexander M. Yeh
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  15. Lawrence Berk
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Corresponding author

Correspondence to Gwen Wyatt.

Ethics declarations

Conflict of interest

Dr. Singh reports that his institution has received per-case reimbursement from RTOG. Dr. Yom reports a research grant from Genentech, Inc. and royalties from UpToDate, Inc.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Informed consent

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

Appendix: The Head and Neck Symptom Scale of the University of Washington Quality of Life Questionnaire (UWHNSS)

Appendix: The Head and Neck Symptom Scale of the University of Washington Quality of Life Questionnaire (UWHNSS)

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Wyatt, G., Pugh, S.L., Wong, R.K.W. et al. Xerostomia health-related quality of life: NRG oncology RTOG 0537. Qual Life Res 25, 2323–2333 (2016). https://doi.org/10.1007/s11136-016-1255-0

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  • DOI: https://doi.org/10.1007/s11136-016-1255-0

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