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A Phase III 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
Presented at the American Society for Therapeutic Radiology and Oncology Meeting, San Francisco, November 2001 and the Canadian Association of Radiation Oncologists Annual Meeting, Toronto, October 2002.
Raimond K. W. Wong * *AGlenn W. Jones * *, Stephen M. Sagar * *, Angelica-Fargas Babjak and Tim Whelan * *
Hamilton, ON L8V 2C5 Canada. Tel: 905-387-9495; Fax: 905-575-6326
A Reprint requests to: Raimond K. W. Wong, M.B.B.S., Department of Radiation Oncology, Hamilton Regional Cancer Centre, 699 Concession St.,
[*]Department of Medicine, Division of Radiation Oncology, McMaster University, Hamilton, ON, Canada[]Department of Anaesthesia, McMaster University, Hamilton, ON, Canada[]Department of Radiation Oncology, Hamilton Regional Cancer Centre, Hamilton, ON, Canada
Abstract
Purpose
Recent studies have suggested that acupuncture may improve radiation-induced xerostomia with an increase in the median salivary flow rate and sustained symptom relief.
An acupuncture-like transcutaneous nerve stimulation method (Codetron) without invasive needles was developed to mimic acupuncture treatment. This Phase III study examined the effectiveness of Codetron in treating radiation-induced xerostomia.
Methods and materials
Patients with symptomatic xerostomia after radical radiotherapy for head-and-neck cancer but with evidence of residual salivary function were recruited into the study.
Two 6-week courses of Codetron treatment of acupuncture points preselected according to traditional Chinese medicine principles were given with a 2-week break between each course. Basal and citric acid-primed whole saliva production were measured at baseline and up to 1 year after treatment completion.
Xerostomia symptoms were assessed by a five-item xerostomia symptom questionnaire with a visual analog scale and quality of life was evaluated using the Head and Neck Radiotherapy Questionnaire.
Results
We enrolled 46 patients in the study. All patients had received radiotherapy doses of 50 Gy to bilateral head-and-neck fields, including the parotid glands.
Of the 46 patients, 37 completed the follow-up assessments at 3 and 6 months after treatment completion.
No Codetron treatment-related complications occurred.
Improvement in xerostomia symptoms was noted, with a mean increase in the visual analog scale score of 86 (p < 0.0005) and 77 (p < 0.0001) at 3 and 6 months after treatment completion, respectively.
For all patients, the increase in the mean basal and citric acid-primed whole saliva production at 3 and 6 months after treatment completion was also statistically significant (p < 0.001 and p < 0.0001, respectively).
No statistically significant change in the quality-of-life evaluation compared with baseline was observed.
Conclusion
The results suggest that Codetron treatment improves whole saliva production and related symptoms in patients with radiation-induced xerostomia.
The treatment effects were sustained for at least 6 months after Codetron treatment completion.
A prospective randomized Phase III trial with appropriate controls is being planned.
Intl J Radiation Oncology, Biology, Physics
Volume
57
Issue 2 (1 October 2003) Pages 472-480
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