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)