ARIX: the effectiveness of group Acupuncture in the treatment of Radiation Induced Xerostomia (dry mouth)
| ISRCTN | ISRCTN13130687 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13130687 |
| Secondary identifying numbers | N/A |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Richard Simcock
Scientific
Scientific
Sussex Cancer Centre
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
Study information
| Study design | Interventional multicentre randomised phase III crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 outcome measures | 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. |
| Overall study start date | 15/10/2009 |
| Completion date | 31/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 patients |
| 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
- England
- United Kingdom
Study participating centre
Sussex Cancer Centre
Brighton
BN2 5BE
United Kingdom
BN2 5BE
United Kingdom
Sponsor information
Brighton and Sussex Medical School (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Mr Scott Harfield
Royal Sussex County Hospital
Research & Development Directorate
Clinical Investigation & Research Unit
Eastern Road
Brighton
BN2 5BE
England
United Kingdom
| Website | http://www.bsuh.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/01qz7fr76 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (ref: C54/A7374)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2013 | Yes | No |
