Skip to main content
Top
Gepubliceerd in:

01-09-2016

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

Auteurs: Gwen Wyatt, Stephanie L. Pugh, Raimond K. W. Wong, Stephen Sagar, Anurag K. Singh, MD, Shlomo A. Koyfman, Phuc F. Nguyen-Tân, Sue S. Yom, Francis S. Cardinale, Khalil Sultanem, Ian Hodson, Greg A. Krempl, Barbara Lukaszczyk, Alexander M. Yeh, Lawrence Berk

Gepubliceerd in: Quality of Life Research | Uitgave 9/2016

Log in om toegang te krijgen
share
DELEN

Deel dit onderdeel of sectie (kopieer de link)

  • Optie A:
    Klik op de rechtermuisknop op de link en selecteer de optie “linkadres kopiëren”
  • Optie B:
    Deel de link per e-mail

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.
Bijlagen
Alleen toegankelijk voor geautoriseerde gebruikers
Literatuur
1.
go back to reference Dirix, P., Nuytx, S., Vander Poorten, V., Delaere, P., & Van den Bogaert, W. (2008). The influence of xerostomia after radiotherapy on quality of life: Results of a questionnaire in head and neck cancer. Supportive Care in Cancer, 16(2), 171–179.CrossRefPubMed Dirix, P., Nuytx, S., Vander Poorten, V., Delaere, P., & Van den Bogaert, W. (2008). The influence of xerostomia after radiotherapy on quality of life: Results of a questionnaire in head and neck cancer. Supportive Care in Cancer, 16(2), 171–179.CrossRefPubMed
2.
go back to reference Scarantino, C. L. F., Swann, R. S., et al. (2006). 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, 4(5), 252–258. Scarantino, C. L. F., Swann, R. S., et al. (2006). 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, 4(5), 252–258.
3.
go back to reference Wong, R., Jones, G., Sagar, S., Babjak, A., & Whelan, T. (2003). 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, 57(2), 472–480.CrossRef Wong, R., Jones, G., Sagar, S., Babjak, A., & Whelan, T. (2003). 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, 57(2), 472–480.CrossRef
4.
go back to reference Wong, R. K. W., Deshmukh, S., Wyatt, G., et al. (2015). RTOG 0537 Phase 2/3 study comparing Acupuncture-like transcutaneous electrical nerve stimulation versus pilocarpine in treating early radiation-induced xerostomia: Phase 3 preliminary analysis. International Journal of Radiation Oncology Biology Physics, 92(2), 220–227.CrossRef Wong, R. K. W., Deshmukh, S., Wyatt, G., et al. (2015). RTOG 0537 Phase 2/3 study comparing Acupuncture-like transcutaneous electrical nerve stimulation versus pilocarpine in treating early radiation-induced xerostomia: Phase 3 preliminary analysis. International Journal of Radiation Oncology Biology Physics, 92(2), 220–227.CrossRef
5.
go back to reference Wong, R., James, J., Sagar, S., et al. (2012). 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, 118(17), 4244–4252.CrossRefPubMedPubMedCentral Wong, R., James, J., Sagar, S., et al. (2012). 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, 118(17), 4244–4252.CrossRefPubMedPubMedCentral
6.
go back to reference Wong, R., Deshmukh, S., Wyatt, G., et al. (2013). RTOG 0537 phase 2/3 study comparing acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) versus pilocarpine (PC) in treating early radiation-induced xerostomia (RIX): Phase 3 preliminary analysis. International Journal of Radiation Oncology Biology Physics, 87(2), S116.CrossRef Wong, R., Deshmukh, S., Wyatt, G., et al. (2013). RTOG 0537 phase 2/3 study comparing acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) versus pilocarpine (PC) in treating early radiation-induced xerostomia (RIX): Phase 3 preliminary analysis. International Journal of Radiation Oncology Biology Physics, 87(2), S116.CrossRef
7.
go back to reference Zelen, M. (1974). The randomization and stratification of patients to clinical trials. Journal of Chronic Disease, 27(7–8), 365–375.CrossRef Zelen, M. (1974). The randomization and stratification of patients to clinical trials. Journal of Chronic Disease, 27(7–8), 365–375.CrossRef
8.
go back to reference Hassan, S., & Weymuller, E, Jr. (1993). Assessment of quality of life in head and neck cancer patients. Head and Neck, 15(6), 485–496.CrossRefPubMed Hassan, S., & Weymuller, E, Jr. (1993). Assessment of quality of life in head and neck cancer patients. Head and Neck, 15(6), 485–496.CrossRefPubMed
9.
go back to reference Weymuller, E, Jr, Alsarraf, R., Yueh, B., Deleyiannis, F., & Coltera, M. (2001). Analysis of the performance characteristics of the University of Washington Quality of Life instrument and its modification (UW-QOL-R). Archives of Otolaryngology: Head and Neck Surgery, 127(5), 489–493.CrossRef Weymuller, E, Jr, Alsarraf, R., Yueh, B., Deleyiannis, F., & Coltera, M. (2001). Analysis of the performance characteristics of the University of Washington Quality of Life instrument and its modification (UW-QOL-R). Archives of Otolaryngology: Head and Neck Surgery, 127(5), 489–493.CrossRef
10.
go back to reference Pomeranz B, Niznik G. Codetron (1987). A new electrotherapy device overcomes the habituation problems of conventional TENS devices. American Journal of Electromedicine, 2, 22–26. Pomeranz B, Niznik G. Codetron (1987). A new electrotherapy device overcomes the habituation problems of conventional TENS devices. American Journal of Electromedicine, 2, 22–26.
11.
go back to reference Dirix, P., Nuyts, S., & Van den Bogaert, W. (2006). Radiation-induced xerostomia in patients with head and neck cancer. Cancer, 107, 2525–2534.CrossRefPubMed Dirix, P., Nuyts, S., & Van den Bogaert, W. (2006). Radiation-induced xerostomia in patients with head and neck cancer. Cancer, 107, 2525–2534.CrossRefPubMed
12.
go back to reference Hoffman, K., Pugh, S., James, J., et al. (2014). The impact of concurrent granulocyte macrophage-colony stimulating factor on quality of life in head and neck cancer patients: Results of the randomized placebo-controlled Radiation Therapy Oncology Group 9901 trial. Quality of Life Research, 23, 1841–1858.CrossRefPubMedPubMedCentral Hoffman, K., Pugh, S., James, J., et al. (2014). The impact of concurrent granulocyte macrophage-colony stimulating factor on quality of life in head and neck cancer patients: Results of the randomized placebo-controlled Radiation Therapy Oncology Group 9901 trial. Quality of Life Research, 23, 1841–1858.CrossRefPubMedPubMedCentral
13.
go back to reference SAS Software, Version 9.2 of the SAS system for windows. Copyright 2002–2003 SAS Institute Inc., Cary, NC, USA. SAS Software, Version 9.2 of the SAS system for windows. Copyright 20022003 SAS Institute Inc., Cary, NC, USA.
14.
go back to reference Kannan, V., Bapsy, P., Anantha, N., Doval, D., Vaithianathan, H., & Benumathy, G. (1997). Efficacy and safety of granulocyte macrophage-colony stimulating factor (GM-CSF) on the frequency and severity of radiation mucositis in patients with head and neck carcinoma. International Journal of Radiation Oncology Biology Physics, 37(5), 1005–1010.CrossRef Kannan, V., Bapsy, P., Anantha, N., Doval, D., Vaithianathan, H., & Benumathy, G. (1997). Efficacy and safety of granulocyte macrophage-colony stimulating factor (GM-CSF) on the frequency and severity of radiation mucositis in patients with head and neck carcinoma. International Journal of Radiation Oncology Biology Physics, 37(5), 1005–1010.CrossRef
15.
go back to reference Chi, K., Chen, C., Chan, W., Chow, K., Chen, S., & Yen, S. (1995). Effect of granulocyte-macrophage colony-stimulating factor on oral mucositis in head and neck cancer patients after cisplatin, fluorouracil, and leucovorin chemotherapy. Journal of Clinical Oncology, 13(10), 2620–2628.PubMed Chi, K., Chen, C., Chan, W., Chow, K., Chen, S., & Yen, S. (1995). Effect of granulocyte-macrophage colony-stimulating factor on oral mucositis in head and neck cancer patients after cisplatin, fluorouracil, and leucovorin chemotherapy. Journal of Clinical Oncology, 13(10), 2620–2628.PubMed
16.
go back to reference Sprinzl, G., Galvan, O., de Vries, A., Ulmer, H., Gunkel, A., & Lukas, P. (2001). Local application of granulocyte-macrophage colony stimulating factor (GM-CSF) for the treatment of oral mucositis. European Journal of Cancer, 37(16), 2003–2009.CrossRefPubMed Sprinzl, G., Galvan, O., de Vries, A., Ulmer, H., Gunkel, A., & Lukas, P. (2001). Local application of granulocyte-macrophage colony stimulating factor (GM-CSF) for the treatment of oral mucositis. European Journal of Cancer, 37(16), 2003–2009.CrossRefPubMed
17.
go back to reference Sloan, J. A., Berk, L., Roscoe, J., et al. (2007). Integrating patient-reported outcomes into cancer symptom management clinical trials supported by the National Cancer Institute-sponsored clinical trials networks. Journal of Clinical Oncology, 25(32), 5070–5077.CrossRefPubMed Sloan, J. A., Berk, L., Roscoe, J., et al. (2007). Integrating patient-reported outcomes into cancer symptom management clinical trials supported by the National Cancer Institute-sponsored clinical trials networks. Journal of Clinical Oncology, 25(32), 5070–5077.CrossRefPubMed
18.
go back to reference Delporte, C., O’Connell, B., Xinjun, H., et al. (1997). Increased fluid secretion after adenoviral-mediated transfer of the aquaporin-1 cDNA to irradiated rat salivary glands. Proceedings of the National Academy of Sciences USA, 94, 3268–3278.CrossRef Delporte, C., O’Connell, B., Xinjun, H., et al. (1997). Increased fluid secretion after adenoviral-mediated transfer of the aquaporin-1 cDNA to irradiated rat salivary glands. Proceedings of the National Academy of Sciences USA, 94, 3268–3278.CrossRef
19.
go back to reference Lombaert, I., Wierenga, P., Kok, T., et al. (2006). Mobilization of bone marrow stem cells by granulocyte colony-stimulating factor ameliorates radiation-induced damage to salivary glands. Clinical Cancer Research, 12, 1804–1812.CrossRefPubMed Lombaert, I., Wierenga, P., Kok, T., et al. (2006). Mobilization of bone marrow stem cells by granulocyte colony-stimulating factor ameliorates radiation-induced damage to salivary glands. Clinical Cancer Research, 12, 1804–1812.CrossRefPubMed
20.
go back to reference Sikorskii, A., Wyatt, G., Tamkus, D., Victorson, D., Rahbar, M., & Ahn, S. (2012). Concordance between patient reports of cancer-related symptoms and medical records documentation. Journal of Pain and Symptom Management, 44(3), 362–372.CrossRefPubMedPubMedCentral Sikorskii, A., Wyatt, G., Tamkus, D., Victorson, D., Rahbar, M., & Ahn, S. (2012). Concordance between patient reports of cancer-related symptoms and medical records documentation. Journal of Pain and Symptom Management, 44(3), 362–372.CrossRefPubMedPubMedCentral
Metagegevens
Titel
Xerostomia health-related quality of life: NRG oncology RTOG 0537
Auteurs
Gwen Wyatt
Stephanie L. Pugh
Raimond K. W. Wong
Stephen Sagar
Anurag K. Singh, MD
Shlomo A. Koyfman
Phuc F. Nguyen-Tân
Sue S. Yom
Francis S. Cardinale
Khalil Sultanem
Ian Hodson
Greg A. Krempl
Barbara Lukaszczyk
Alexander M. Yeh
Lawrence Berk
Publicatiedatum
01-09-2016
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 9/2016
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-016-1255-0