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.
• 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 xerostomia symptoms recorded• Measurement of unstimulated and stimulated saliva production using Schirmer strips• Patients’ expectations recorded at baseline
1. Background
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
2. Method
4. Acupuncture technique
3. Trial design
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.
• 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
Acupuncture PointsAuricular 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
6. Results
7. Conclusion
REFERENCES:1.Blom M.et al Acupuncture treatment of patients with radiation-induced xerostomia EJC 32(3):182-190,19962.Wong RK.et al Phase 2 results from Radiation Therapy Oncology Group Study 0537 Cancer, article in press, 20123.Simcock R, Fallowfield L, Jenkins V et al Group acupuncture to relieve radiation induced xerostomia: a feasibility study. Acupuncture Medicine 27(3), 109-13, 20094.Johnstone P, Niemtzow R, Riffenburgh R. Acupuncture for xerostomia. Cancer 94:1151-6, 2002
• 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
Patients with head and neck cancer treated with radiotherapy at least 18 months ago
who complain of xerostomia
Randomise
Baseline assessmentsBaseline assessments
Group acupuncture once a week for 8 weeks
weeks 1 - 8
Assessment at weeks 5 & 9
Group nurse/radiographer specialist led educational oral care package
weeks 1 & 5
Crossover to alternate treatment arm
Group acupuncture once a week for 8 weeks
weeks 13 - 20
Assessment at weeks 5 & 9
Group nurse/radiographer specialist
led educational oral care package weeks 13 & 17
Assessment at weeks
13, 17 & 21
Assessment at weeks
13, 17 & 21
Further assessment 3 - 6
months after acupuncture
Group 1; O-A (n=74) Group 2; A-O (n=70) Total (n=144)
Age Median (Range) 60 (43-79) 57 (41-83) 58 (41-83)
Tumour site
Oral cavity
Oropharynx
Nasopharynx
Larynx/Hypopharynx
Parotid gland
Occult/unknown
8
52
3
7
2
2
3
48
3
8
0
8
11
100
6
15
2
10
Other Treatments
Surgery
Chemotherapy
32
46
31
48
63
94
Radiotherapy technique
2D orthogonal fields
Conformal 3D
IMRT
Not recorded
11
61
1
1
15
54
0
1
26
115
1
2
Dose to PTVprimary Gy
Mean (Range)
63.5 (50-70)
65.6 (55-70)
64.6 (50-70)
RT completion to randomisation (months)
Median (range)
39.5 (18-75)
42.0 (18-104)
41.0 (18-104)
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