ARIX: the effectiveness of group Acupuncture in the treatment of Radiation Induced Xerostomia (dry mouth)
| ISRCTN | ISRCTN13130687 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13130687 |
| Protocol serial number | N/A |
| Sponsor | Brighton and Sussex Medical School (UK) |
| Funder | Cancer Research UK (CRUK) (UK) (ref: C54/A7374) |
- Submission date
- 29/09/2009
- Registration date
- 03/11/2009
- Last edited
- 09/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Sussex Cancer Centre
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional multicentre randomised phase III crossover trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | ARIX: a randomised phase III crossover trial to examine the effectiveness of group Acupuncture in the treatment of Radiation Induced Xerostomia |
| Study acronym | ARIX |
| Study objectives | To determine whether patients suffering with chronic radiation induced xerostomia experience a reduction in key xerostomia symptoms following treatment with acupuncture in a group setting. |
| Ethics approval(s) | Brighton East Research Ethics Committee, 15/09/2009, ref: 09/H1107/81 |
| Health condition(s) or problem(s) studied | Chronic radiation-induced xerostomia |
| Intervention | 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. Eight weekly group sessions, weeks 1 - 8, follow up for 6 months. Patients are randomised equally to either intervention 1, or intervention 2. Four weeks after completion of treatment they crossover to receive the alternate intervention. |
| Intervention type | Other |
| Primary outcome measure(s) |
Patient reported change in severity of chronic dry mouth. |
| Key secondary outcome measure(s) |
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) |
| Completion date | 31/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/10/2009 |
| Date of final enrolment | 31/03/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
BN2 5BE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
