ARIX: the effectiveness of group Acupuncture in the treatment of Radiation Induced Xerostomia (dry mouth)

ARIX: a randomised phase III crossover trial to examine the effectiveness of group Acupuncture in the treatment of Radiation Induced Xerostomia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13130687

Enrollment

150

Registered

2009-11-03

Start date

2009-10-15

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic radiation-induced xerostomia Signs and Symptoms Diseases of salivary glands

Interventions

Intervention 1: Nurse/radiographer specialist-led educational package in oral care (control). Two group sessions, weeks 1 and 5, and follow up for 6 months. Intervention 2: Group acupuncture. Eigh

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients treated with radical radiotherapy for head and neck cancer at least 18 months previously 2. At least one parotid gland within field of radiotherapy 3. Patient complains of xerostomia 4. No clinical sign of local recurrence 5. Age 18 years or over, either sex

Exclusion criteria

Exclusion criteria: 1. Xerostomia caused by reason other than radiotherapy, e.g., Sjogren's disease 2. Previous surgery to more than one parotid gland 3. Currently using pilocarpine 4. Previous acupuncture treatment for this condition 5. Any physical characteristics that could prevent, or complicate, correct needle insertion

Design outcomes

Primary

Measure	Time frame
Patient reported change in severity of chronic dry mouth. Outcomes will be measured at the following timepoints for each intervention: baseline (before delivery of intervention), week 5, week 9, then once more 6 months after completion of acupuncture.	—

Secondary

Measure	Time frame
1. Change in severity of other key xerostomia symptoms (sticky saliva, dry lips, difficulty swallowing, problems with sense of smell, waking at night, need to sip water to relieve a dry mouth, need to sip water to help swallow food) 2. Change in total salivary output measured using Schirmer strips 3. Benefits of regular group meetings to aspects of quality of life for patients experiencing chronic xerostomia 4. Health economic evaluation Outcomes will be measured at the following timepoints for each intervention: baseline (before delivery of intervention), week 5, week 9, then once more 6 months after completion of acupuncture.	—

Measure

Time frame

1. Change in severity of other key xerostomia symptoms (sticky saliva, dry lips, difficulty swallowing, problems with sense of smell, waking at night, need to sip water to relieve a dry mouth, need to sip water to help swallow food) 2. Change in total salivary output measured using Schirmer strips 3. Benefits of regular group meetings to aspects of quality of life for patients experiencing chronic xerostomia 4. Health economic evaluation Outcomes will be measured at the following timepoints for each intervention: baseline (before delivery of intervention), week 5, week 9, then once more 6 months after completion of acupuncture.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026