Sham-controlled, randomised, feasibility trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma

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Abstract

Background

Xerostomia (dry mouth) after head/neck radiation is a common problem among cancer patients. Quality of life (QOL) is impaired, and available treatments are of little benefit. This trial determined the feasibility of conducting a sham-controlled trial of acupuncture and whether acupuncture could prevent xerostomia among head/neck patients undergoing radiotherapy.

Methods

A sham controlled, feasibility trial was conducted at Fudan University Shanghai Cancer Center, Shanghai, China among patients with nasopharyngeal carcinoma undergoing radiotherapy.

To determine feasibility of a sham procedure, 23 patients were randomised to real acupuncture (N = 11) or to sham acupuncture (N = 12). Patients were treated three times/week during the course of radiotherapy. Subjective measures were the Xerostomia Questionnaire (XQ) and MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN). Objective measures were unstimulated whole salivary flow rates (UWSFR) and stimulated salivary flow rates (SSFR). Patients were followed for 1 month after radiotherapy.

Results

XQ scores for acupuncture were significantly lower than sham controls starting in week 3 and lasted through the 1-month follow-up (all P’s <0.001 except for week 3, which was 0.006), with clinically significant differences as follows: week 6 – RR 0.28 [95% confidence interval, 0.10, 0.79]; week 11 – RR 0.17 [95% CI, 0.03, 1.07]. Similar findings were seen for MDASI-HN scores and MDASI-Intrusion scores. Group differences for UWSFR and SSFR were not found.

Conclusions

In this small pilot study, true acupuncture given concurrently with radiotherapy significantly reduced xerostomia symptoms and improved QOL when compared with sham acupuncture. Large-scale, multi-centre, randomised and placebo-controlled trials are now needed.

Introduction

Most patients diagnosed with head/neck cancer receive radiotherapy as part of their cancer treatment. Xerostomia (dry mouth) is a common, often debilitating, side effect of radiotherapy in this population, occurs to some degree in up to 100% of patients and can severely impair quality of life (QOL).1, 2 Patients can experience taste aberrations, dysphagia, odynophagia, difficulty sleeping and speaking and loss of appetite. Due to the decrease in saliva, there can be a reduction in the natural inhibition of bacterial growth in the oral cavity, resulting in increases of caries-forming microbes that can cause bone infection and irreversible nutritional deficits.3

Treatment for radiation-induced xerostomia, for the most part, is palliative. Approaches such as saliva substitutes, chewing gum, sialogogue lozenges and pilocarpine have been attempted with limited benefit.4, 5, 6, 7, 8, 9, 10, 11, 12, 13 Amifostine reduces the incidence and severity of radiation-induced xerostomia but is not universally available, requires parenteral administration and has potential unpleasant side-effects.9

Multiple clinical trials indicate acupuncture can benefit patients with head and neck cancer who have developed radiation-induced xerostomia.14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26 Studies conducted by different groups of investigators both in the United States and Europe have demonstrated positive results. Some have shown relief of symptoms in as few as five treatments,14 with benefits lasting up to 3 years.15 No previous sham-controlled, randomised trials, however, have explored whether acupuncture can prevent xerostomia.

We previously conducted a randomised trial to determine the effects of acupuncture for preventing the development of xerostomia among cancer patients undergoing conventional radiotherapy to the head/neck where an acupuncture group was compared to usual care.27 Group differences in xerostomia symptoms, salivary flow and QOL emerged as early as 3 weeks into radiotherapy and remained statistically and clinically significantly different 6 months after the end of radiotherapy. Although primarily a feasibility trial, this second trial compared true acupuncture with sham acupuncture as a secondary aim. We hypothesised acupuncture would prevent the development of xerostomia and diminish its severity. We also hypothesised participant blinding would be maintained throughout the study.

Section snippets

Materials and methods

This was a 2-arm, randomised, sham-controlled feasibility study. It was approved by Institutional Review Boards at both MD Anderson Cancer Center and Fudan University Shanghai Cancer Center; however, all patients were treated in China. Potential participants were identified by faculty in the Department of Radiation Oncology at Fudan, eligibility was assessed and informed consent was obtained. Patients were recruited between February and August, 2009. The trial was registered at

Results

Of the 32 eligible patients who approached, 23 consented and were randomly assigned to real or sham acupuncture (72% acceptance rate, Fig. 1). One patient in the sham group stopped receiving radiotherapy after 4 weeks but was included in the data analyses for the time points for which they provided data. Otherwise, complete data was available at each time point for all patients. As can be seen in Table 1, the groups were balanced on medical and demographic characteristics. Three patients

Discussion

This is the first randomised, sham-controlled study to investigate whether or not the use of acupuncture given during a course of radiotherapy can reduce the development and severity of xerostomia. For self-report measures, group differences emerged as early as week 3, and remained significant at 1 month after the end of radiotherapy, even without additional acupuncture. Only 25% of patients in the real acupuncture group reported clinically significant symptoms 1 month after the end of

Conflict of interest statement

None declared.

Acknowledgements

Support was provided in part by the United States National Cancer Institute (NCI) grant CA121503 (PI L. Cohen), the NCI Cancer Center Support Grant CA016672 and the Chinese Science and Technology Commission of Shanghai Municipality Grant 05DZ19747 (PI Z. Meng). We thank Drs. Peiying Yang, Zongxing Liao, and Jennifer McQuade for all their support with language, culture and politics. Thank you to the Department of Scientific Publications, The University of Texas MD Anderson Cancer Center for

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