145 patients with radiation induced xerostomia >18 months

1. Patients with head and neck cancer treated with radiotherapy at least 18 months ago who complain of xerostomia Randomise Baseline assessments Baseline assessments Group nurse/radiographer specialist Groupacupunctureonce a week for 8 weeks lededucationaloral care package weeks 1 - 8 weeks 1 & 5 Assessmentat weeks 5 & 9 Assessmentat weeks 5 & 9 Crossover to alternate treatment arm Group acupuncture once a Group nurse/radiographer specialist week for 8 weeks led educational oral care package weeks 13 - 20 weeks 13 & 17 Assessment at weeks Assessment at weeks 13, 17 & 21 13, 17 & 21 Further assessment 3 - 6 months after acupuncture ARIX: Acupuncture for Radiation Induced Xerostomia Simcock R1, Fallowfield L2, Monson K2, Solis –Trapala I3, Parlour L2, Langridge C2, Jenkins V2, 1Brighton and Sussex University Hospitals NHS Trust, 2 SHORE-C, BSMS University of Sussex, 3 MRC Human Nutrition Research, Cambridge,UK 1. Background 4. Acupuncture technique Chronic xerostomia (severe dry mouth) is a major side effect of radiation treatment for head and neck cancer that has a deleterious impact on quality of life. Previous studies suggest that acupuncture may be beneficial in relieving xerostomia symptoms1-2. We previously reported encouraging results from a pilot study3.Patients were treated in groups to reduce costs using a previously developed acupuncture protocol4. We postulated that group interaction may have contributed to the beneficial effects observed. This informed the design of our phase III trial, the largest to date in this area. Acupuncture Points Auricular needles, (0.2 x 7mm) were inserted at : Salivary Gland 2, Modified Point Zero and Shen Men 0.16 x 25mm needles were used bilaterally in LI2 (index finger) and LI20 5. Patient Characteristics 2. Method • 145 patients with radiation induced xerostomia >18 months • post treatment from 7 UK cancer centres • Participants received standardised group sessions of oral • care education and 8 sessions of weekly group • acupuncture in randomised crossover design • Primary outcome: patient reported improvement in dry • mouth • Assessments: • EORTC QLQ C30 + HN35 questionnaires at baseline and • at weeks 5, 9, 13, 17, and 21 • Key xerostomiasymptoms recorded • Measurement of unstimulated and stimulated saliva • production using Schirmerstrips • Patients’ expectations recorded at baseline 6. Results • Mean attendance rate at the acupuncture sessions was 89% and 80% at the oral care sessions • Compared to oral care, following a course of acupuncture, there were significant reductions in patients’ reporting of : • severe dry mouth (OR=2.01, p=0.031) • sticky saliva (OR=1.67, p=0.048) • needing to sip fluids to swallow food (OR = 2.08, p=0.011) • waking at night to drink (OR=1.71, p=0.013) • Mean global QoL score did not change significantly with or between groups • There was no change in either stimulated or unstimulated saliva • There was no correlation between patients’ prior expectations of benefit and participants’ reported outcomes 3. Trial design 7. Conclusion • The ARIX trial has established the efficacy of this acupuncture technique • Future studies are warranted to refine the technique further and to establish benefit in terms of length of treatment and whether booster sessions would maintain efficacy • Group sessions provide a pragmatic and affordable system of delivering acupuncture • Patients considered oral care education to be helpful and reported benefits from meeting other xerostomia sufferers • REFERENCES: • Blom M.et al Acupuncture treatment of patients with radiation-induced xerostomia EJC 32(3):182-190,1996 • Wong RK.et al Phase 2 results from Radiation Therapy Oncology Group Study 0537 Cancer, article in press, 2012 • Simcock R, Fallowfield L, Jenkins V et al Group acupuncture to relieve radiation induced xerostomia: a feasibility study. Acupuncture Medicine 27(3), 109-13, 2009 • Johnstone P, Niemtzow R, Riffenburgh R. Acupuncture for xerostomia. Cancer 94:1151-6, 2002 Brighton & Sussex Medical School sponsored the study; approved by Brighton East Ethics Committee (09/H1107/81). ISRCTN13130687. The trial was performed according to STRICTA standards . Funded by Cancer Research UK (award no. C54/A7374). Thank you to all the patients, centres and therapists that took part.