Condition category
Signs and Symptoms
Date applied
29/09/2009
Date assigned
03/11/2009
Last edited
09/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Simcock

ORCID ID

Contact details

Sussex Cancer Centre
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom

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 measures

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

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

http://www.bsuh.nhs.uk/

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23104718

Publication citations

Additional files

Editorial Notes