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Trial registered on ANZCTR


Registration number
ACTRN12615000924550
Ethics application status
Approved
Date submitted
14/08/2015
Date registered
4/09/2015
Date last updated
25/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Simple solutions to gastro-intestinal symptoms in chemotherapy patients
Scientific title
Can upper gastric chemotherapy symptoms be predicted by taste genetics and will mouth wash solutions of water, salt, sodium bicarbonate, sugar, ginger or peppermint water improve taste changes, nausea or vomiting in patients receiving chemotherapy of cyclophosphamide or 5-FU
Secondary ID [1] 287278 0
Nil
Universal Trial Number (UTN)
U1111-1173-2105
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients receiving intravenous chemotherapy of cyclophosphamide or 5 fluorouracil 295914 0
Cancer 295961 0
Condition category
Condition code
Oral and Gastrointestinal 296162 296162 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Diet and Nutrition 296164 296164 0 0
Other diet and nutrition disorders
Cancer 296335 296335 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At base line before chemotherapy commmenced genetic test strips will be used to screen for taste sensitivities Genetic taste test strips will be used to screen for genetically inherited taste recognition thresholds using taste testing strips which are impregnated with either 30mg thiourea, 30mg phenylthiocarbamide (PTC), or 30mg sodium benzoate. Participants were asked to trial each taste test strip in a random order by applying a strip to their moistened tongue and reporting whether it had no taste or tasted bitter, salty, sour, sweet, or any other taste. Patients will be classified as non-tasters with no taste reported, tasters when a recognisable taste is identified, and hyper-tasters if a strong taste was elicited.
Number of taste buds counted by placing a drop of blue food colouring on tip of dry tongue A 6mm round hole in filter paper placed over the area dyed and the number of papillae counted within this space.
Patients will be asked about their symptoms during cycle 2. Those reporting symptoms will be asked to trial mouth rinses during cycle 3 when symptoms are reported to be greatest.
Mouth washes of various common oral fluids will be trialled for 12 hours in random order as often as patient requires but at least twice for six consecutive days with overnight wasout periods. They will complete a questionaire daily to see which mouth washes improve taste and symptoms in chemotherapy.
a)Distilled cold water 500ml
b)Salt 5 g in 500ml cold water
c)Sodium bicarbonate 5 g in 500ml cold water
d)Sugar 25g in 500ml cold water
e)Ginger 2 gram in 500ml cold water
f) Peppermint oil 0.2 ml in 500ml coldwater

Monitoring for adherence is by questionaire completion and container return.
Intervention code [1] 292588 0
Lifestyle
Intervention code [2] 292726 0
Treatment: Other
Comparator / control treatment
Comparison of 5 different solution with distilled water
Control group
Active

Outcomes
Primary outcome [1] 295840 0
To determine if the genetics of taste can predict development of upper gastric symptoms in patients receiving chemotherapy.The composite outcomes use genetic taste testing and counting number of taste buds.
Timepoint [1] 295840 0
Baseline before commencement of chemotherapy
Secondary outcome [1] 316686 0
Number of participants with any improvements in taste and symptoms (composite), assessed using questionnaire designed for this study for each of the mouthwashes over 6 days during cycle3 of chemotherapy.
Timepoint [1] 316686 0
Outcomes will be assessed during chemotherapy Cycle 3 Days 3-10. Each mouthwash response will be assessed by questionaire after each 12 hour trial

Eligibility
Key inclusion criteria
Competent patients aged 18-85 to receive intravenous chemotherapy of cyclophosphamide on regimens AC, TC, AC-T or FEC-D or 5-FU on regimens Modified FOLFOX6 or modified de gramont
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable or unwilling to sign the consent form
Patients with head and neck cancer
Patients having concurrent radiotherapy
Patients already receiving chemotherapy

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)
Patients planned to receive chemotherapy of cyclophosphamide or 5-FU will be recruited from the Austin Health oncology day care outpatient clinic on the chemotherapy information day.
Patients will be asked about GI symptoms during cycle 2 of chemotherapy and those reporting symptoms will be allocated the 6 solutions to be trialled in randomised order determined by computerised sequence generation by a uninvolved person.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
All the patrticipants receive all the interventions in different sequences during the study thereby acting as their own control. On selection of the solution that improves that patients symptoms the most, the solution code will be revealled and the patient will continue using this solution as required
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A convenience sample of 60 patients is to be recruited for taste genetics analysis.
From a sample file audit of patients who met inclusion criteria ~60% reported upper GI symptoms. Therefore it is estimated a sample of 60 patients planned to undergo the study chemotherapy should result in a convenience sample of 36 patients to trial the mouth washes as a secondary outcome.
The participants' demographic, clinical and laboratory characteristics will be compared using independent sample t-tests for continuous data and Fisher exact tests for ordinal data. The strength of association between genetic taste testing and upper GI symptoms will be estimated using the Spearman rank correlation method. Frequency of response will be used for upper GI symptoms and the relationships between response to solutions and nature of the mouthwash (sugar, salt, sodium bicarbonate, ginger, mint and water) will be dichotomised as better/much better versus worse/same then analysed using random-effect logistic regression model. Statistical significance will be set at p<0.05

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2016
Actual
1/03/2016
Date of last participant enrolment
Anticipated
3/12/2017
Actual
5/02/2018
Date of last data collection
Anticipated
Actual
10/03/2018
Sample size
Target
60
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4196 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 10109 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 291838 0
Charities/Societies/Foundations
Name [1] 291838 0
Austin Medical Research Foundation
Country [1] 291838 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Austin Health
145 Studley Rd
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 290506 0
None
Name [1] 290506 0
Address [1] 290506 0
Country [1] 290506 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293356 0
Austin Human Ethics Committee
Ethics committee address [1] 293356 0
Austin Health
145 Studley Rd
Heidelberg
Victoria 3084
Ethics committee country [1] 293356 0
Australia
Date submitted for ethics approval [1] 293356 0
17/09/2015
Approval date [1] 293356 0
24/02/2016
Ethics approval number [1] 293356 0
HREC/15/Austin/414

Summary
Brief summary
The primary purpose of this study is to determine whether simple mouthwashes can decrease symptoms of poor appetite, taste changes, nausea and vomiting due to chemotherapy. The study also aims to predict which patients will develop the most symptoms based on genetic and taste bud counting tests.
Who is it for? You may be eligible to join this study if you are aged 18-85 years and due to receive intravenous chemotherapy of cyclophosphamide or 5-FU.
Study details Prior to the first cycle of chemotherapy, genetic characteristics of each participant's taste will be tested using saliva samples, and the number of taste buds on the tongue will be counted. After 2 cycles of chemotherapy, participants will be asked to rate their symptoms of appetite, taste changes, nausea and vomiting. Patients with these symptoms will then test 6 different simple mouthwashes, including salt, sodium bicarbonate, sugar, ginger and peppermint oil, in a random order for 1 day per mouthwash. Patients will be asked to rate the effectiveness of each of the mouthwashes in reducing symptoms via questionnaire.
It is hoped that these simple mouthwashes may be able to minimise symptoms, thus improving chemotherapy patient well-being, potentially increasing oral intake and thereby improving nutritional status.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59538 0
Ms Karen Manley
Address 59538 0
Austin Health
145 Studley Rd
Heidelberg
Vic 3084
Country 59538 0
Australia
Phone 59538 0
+61 3 94965646
Fax 59538 0
+61 3 94963168
Email 59538 0
[email protected]
Contact person for public queries
Name 59539 0
Karen Manley
Address 59539 0
Austin Health
145 Studley Rd
Heidelberg
Vic 3084
Country 59539 0
Australia
Phone 59539 0
+61 3 94965646
Fax 59539 0
+61 3 94963168
Email 59539 0
[email protected]
Contact person for scientific queries
Name 59540 0
Karen Manley
Address 59540 0
Austin Health
145 Studley Rd
Heidelberg
Vic 3084
Country 59540 0
Australia
Phone 59540 0
+61 3 94965646
Fax 59540 0
+61 3 94963168
Email 59540 0
[email protected]

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