Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2016 Sep;25(9):2323-33.
doi: 10.1007/s11136-016-1255-0. Epub 2016 Feb 25.

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

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

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

Gwen Wyatt et al. Qual Life Res. 2016 Sep.

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.

Keywords: Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS); Head and neck cancer; Radiation-induced xerostomia (RIX); Symptom management.

PubMed Disclaimer

Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1
NRG Oncology/RTOG 0537 Study Schema
Fig 2
Fig 2
CONSORT Diagram
Fig. 3
Fig. 3
A Comparison of ALTENS vs. PC in Treating Radiation-Induced Xerostomia using the RM-UWHNSS
None
See this image and copyright information in PMC

References

    1. Dirix P, Nuytx S, Vander Poorten V, Delaere P, Van den Bogaert W. The influence of xerostomia after radiotherapy on quality of life: results of a questionnaire in head and neck cancer. Supportive Care in Cancer. 2008;16(2):171–179. - PubMed
    1. Scarantino CLF, Swann RS, et al. Effect of pilocarpine during radiation therapy: Results of RTOG 97-09, a phase III randomized study in head and neck cancer patients. Journal of Support Oncology. 2006;4(5):252–258. - PubMed
    1. Wong R, Jones G, Sagar S, Babjak A, Whelan T. A Phase I-II study in the use of acupuncture-like transcutaneous nerve stimulation in the treatment of radiation-induced xerostomia in head-and-neck cancer patients treated with radical radiotherapy. International Journal of Radiation Oncology Biology Physics. 2003 Oct 1;57(2):472–480. - PubMed
    1. Wong R, Deshmukh S, Wyatt G, et al. Acupuncture-like Transcutaneous Electrical Nerve Stimulation versus Pilocarpine in Treating Early Radiation-Induced Xerostomia: Results of RTOG 0537 Phase 3 Study. International Journal of Radiation Oncology Biology Physics. 2015 In press. - PMC - PubMed
    1. Wong R, James J, Sagar S, et al. Phase 2 results from Radiation Therapy Oncology Group Study 0537: a phase 2/3 study comparing acupuncture-like transcutaneous electrical nerve stimulation versus pilocarpine in treating early radiation-induced xerostomia. Cancer. 2012 Sep 1;118(17):4244–4252. - PMC - PubMed

Publication types