Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
ARIX: a randomised phase III crossover trial to examine the effectiveness of group Acupuncture in the treatment of Radiation Induced Xerostomia
Acronym
ARIX
Study hypothesis
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
Brighton East Research Ethics Committee, 15/09/2009, ref: 09/H1107/81
Study design
Interventional multicentre randomised phase III crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase III
Drug names
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 trial start date
15/10/2009
Overall trial end date
31/03/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150 patients
Participant 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
Recruitment start date
15/10/2009
Recruitment end date
31/03/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Sussex Cancer Centre
Brighton
BN2 5BE
United Kingdom
Sponsor information
Organisation
Brighton and Sussex Medical School (UK)
Sponsor details
c/o Mr Scott Harfield
Royal Sussex County Hospital
Research & Development Directorate
Clinical Investigation & Research Unit
Eastern Road
Brighton
BN2 5BE
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C54/A7374)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23104718