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Trial registered on ANZCTR


Trial ID
ACTRN12614000943640
Ethics application status
Approved
Date submitted
27/08/2014
Date registered
3/09/2014
Date last updated
1/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Chewing gum to relieve thirst in chronic heart failure
Scientific title
A randomised controlled trial of chewing gum to relieve thirst in chronic heart failure
Secondary ID [1] 285238 0
Nil
Universal Trial Number (UTN)
Trial acronym
RELIEVE- CHF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic heart failure 292870 0
Condition category
Condition code
Cardiovascular 293167 293167 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves the use of chewing gum (Xylitol, Epic Dental LLC peppermint flavour) to reduce thirst in patients with CHF. Consenting subjects will be randomised to each study arms. Study participants allocated to the chewing gum will be instructed to chew sugar free Xylitol, Epic Dental LLC peppermint flavour gum gently, for at least 10 minutes, six times a day and as desired throughout the day when the mouth feels dry or when they are thirsty. Participants in the no chewing gum group will instructed to continue with what they normally use to relieve their thirst.
Participants will continue the use of chewing gum for 2 weeks as part of the study protocol. After the 2 week intervention if subjects perceive there has been benefit in the use of chewing gum and the patient wishes to continue using the gum, they are allowed to do so.
Monitoring of adherence to the intervention is performed through self- reporting. At the end of the trial participants will be asked to report their adherence to the intervention and if they are continuing to use the chewing gum.
Intervention code [1] 290113 0
Lifestyle
Intervention code [2] 290114 0
Behaviour
Comparator / control treatment
Any strategies that participants normally use to relieve their thirst e.g. ice chips, small sips of water, lozenges, artificial saliva
Control group
Active

Outcomes
Primary outcome [1] 293022 0
Change in the level of perceived thirst in the short term (average of 24 hours each day for 4 days). This outcome will be assessed using a 100mm visual analogue scale and a numeric rating scale (0-10).
Timepoint [1] 293022 0
Daily for days 1-4 of treatment (chewing gum)/control period
Secondary outcome [1] 310191 0
Change in the level of perceived thirst in the longer term (7 days, 2 weeks and 4 weeks). This outcome will be assessed using a 100mm visual analogue scale and a numeric rating scale (0-10).
Timepoint [1] 310191 0
At days 7, 14 and 28
Secondary outcome [2] 310276 0
Improvements in health related quality of life (HRQoL). This outcome will be assessed using the Kansas City Cardiomyopathy Questionnaire.

Timepoint [2] 310276 0
At 4 weeks after randomisation
Secondary outcome [3] 310277 0
Effect of chewing gum on weight stability over the study period. This will be assessed using weight measurements provided by the participants.
Timepoint [3] 310277 0
Daily for days 1-4, at day 7, 14 and 28 of treatment/control period
Secondary outcome [4] 310278 0
Views and perception of CHF patients on the use of chewing gum. Participants will be asked what their views and perception of the use of chewing gum over the phone.
Timepoint [4] 310278 0
At 4 weeks after randomisation

Eligibility
Key inclusion criteria
1. Aged >18 years old
2. Heart failure as either primary or secondary diagnosis (as per NHFA and ESC guidelines)
Definition:
CHF: Is a complex syndrome characterised by underlying cardiac dysfunction (either associated with impaired or preserved systolic function) and typical symptoms of exercise intolerance.
CHF with diastolic dysfunction: CHF with normal or near normal left ventricular (LV) ejection fraction (EF), normal or near normal LV volume, and evidence of diastolic dysfunction (e.g. abnormal pattern of LV filling and elevated filling pressures)[R][R].
3. On oral loop diuretics
4. Able to safely chew and swallow
5. Able to provide informed consent
6. Able to read, speak and understand English
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. On intravenous inotropes. Patients will be eligible once they have been weaned off the intravenous inotrope.
2. Unable to provide informed consent
3. People using chewing gum regularly
4. Restricted chewing and/or swallowing (i.e. due to dysphagia or other impairment)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be identified through inpatient lists and outpatient clinic lists by the trial co-ordinator. The trial co-ordinator will also approach the patients and invite them to participate in the study. Patients will be given the opportunity to read the information and consent form. Prior to randomisation, baseline data (includes demographic profile, clinical status, comorbidities, results of their physical examination, level of thirst and quality of life) for each participant will be taken and recorded in the appropriate case report forms. If the patient meets the eligibility criteria, they are then randomised to either study arm 1: chewing gum (intervention group) or study arm 2: no chewing gum (control group) using block randomisation and computer generated numbers. Allocation involves contacting the Research Administrative Coordinator at the Centre for Cardiovascular & Chronic Care of the allocation schedule which is "offsite".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization of participants will be performed through the Research Administrative Coordinator at the Centre for Cardiovascular & Chronic Care using a block randomisation and computer generated random numbers. The investigators will not have access to the randomisation schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on previous assessment of thirst by Philipson et al, we estimate the baseline level of thirst to be 5 and the standard deviation to be 2. To detect a 1 point difference in the level of thirst with a standard deviation of 2 points, we estimated a sample size of 65 per group is needed with a 2 sided 5% significance level and 81% power. When taking into account a loss to follow-up of 10% per group, 144 participants (72 per group) are required to be enrolled in the study.

Descriptive statistics, univariate analysis and correlations to document the distribution, central tendency and dispersion as well as the associations between outcomes on study questionnaires and clinical variables. Multivariate analysis will be undertaken to determine the contribution of clinical and non-clinical factors to clinical outcomes where appropriate.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2915 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 8639 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 289855 0
University
Name [1] 289855 0
University of Technology, Sydney
Address [1] 289855 0
15 Broadway (PO Box 123) Ultimo NSW 2007
Country [1] 289855 0
Australia
Primary sponsor type
University
Name
University of Technology, Sydney
Address
15 Broadway (PO Box 123) Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 288536 0
None
Name [1] 288536 0
Address [1] 288536 0
Country [1] 288536 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291578 0
St Vincent's Human Research Ethics Committee
Ethics committee address [1] 291578 0
Level 6, de Lacy building, 390 Victoria Street, Darlinghurst, NSW, 2010
Ethics committee country [1] 291578 0
Australia
Date submitted for ethics approval [1] 291578 0
Approval date [1] 291578 0
22/07/2014
Ethics approval number [1] 291578 0
HREC/14/SVH/171

Summary
Brief summary
Chronic heart failure is a progressive and burdensome syndrome with thirst as a major reason for non-compliance to self- care practices such as fluid restriction. Due to the life threatening effects of non- compliance to fluid restricted therapy, evidence based interventions are needed to manage thirst. Systematic evaluation of available strategies such as chewing gum is essential in ensuring that the best possible management is provided to CHF patients. The purpose of this study is to test the hypothesis that chewing gum can reduce thirst in people with chronic heart failure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50990 0
A/Prof Christopher Hayward
Address 50990 0
Cardiology Department, St. Vincent's Hospital, 390 Victoria Street, Darlinghurst, NSW, 2010
Country 50990 0
Australia
Phone 50990 0
+61 2 8382 6880
Fax 50990 0
Email 50990 0
cshayward@stvincents.com.au
Contact person for public queries
Name 50991 0
Dr Phillip Newton
Address 50991 0
University of Technology, Sydney Level 3, 235 Jones St, Ultimo NSW 2007 (PO Box 123).
Country 50991 0
Australia
Phone 50991 0
+61(0)411 057 056
Fax 50991 0
Email 50991 0
Phillip.Newton@uts.edu.au
Contact person for scientific queries
Name 50992 0
Dr Phillip Newton
Address 50992 0
University of Technology, Sydney Level 3, 235 Jones St, Ultimo NSW 2007 (PO Box 123).
Country 50992 0
Australia
Phone 50992 0
+61(0)411 057 056
Fax 50992 0
Email 50992 0
Phillip.Newton@uts.edu.au