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Trial registered on ANZCTR
Registration number
ACTRN12620001188921
Ethics application status
Approved
Date submitted
30/08/2020
Date registered
10/11/2020
Date last updated
9/08/2022
Date data sharing statement initially provided
10/11/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
A randomised trial of polaprezinc mouthwash for oral mucositis in cancer patients undergoing stem cell transplantation
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Scientific title
A randomised trial on the effect of topical polaprezinc mouthwash on incidence and severity of oral mucositis in cancer patients undergoing haematopoietic stem cell transplantation
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Secondary ID [1]
302107
0
Nil
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Universal Trial Number (UTN)
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Trial acronym
ToPaZ Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
oral mucositis
318733
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Blood cancer
319370
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Condition category
Condition code
Oral and Gastrointestinal
316748
316748
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Cancer
317336
317336
0
0
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Hodgkin's
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Cancer
317337
317337
0
0
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Leukaemia - Acute leukaemia
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Cancer
317338
317338
0
0
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Leukaemia - Chronic leukaemia
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Cancer
317339
317339
0
0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
317340
317340
0
0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
317341
317341
0
0
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Myeloma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Polaprezinc mouthwash will be compared to sodium bicarbonate mouthwash (standard of care) in addition to saline mouthwash.
Treatment arm: Saline 10mL followed by polaprezinc 5mL four times a day as mouthwash
The concentration of polaprezinc mouthwash: 75mg in 20mL water. Each dose will be provided in a single use syringe.
The treatent duration: from hospital admission to neutrophil recovery (approximately 14-21 days)
Patient will swirl polaprezinc in the mouth for 30 seconds then spit. Used mouthwash syringes will be collected daily to assess adherence.
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Intervention code [1]
318408
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Prevention
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Intervention code [2]
318409
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Treatment: Drugs
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Comparator / control treatment
Control treatment will be sodium bicarbonate mouthwash (standard of care) in addition to saline mouthwash.
Control arm: Saline 10mL followed by sodium bicarbonate 10mL four times a day as mouthwash
The treatment duration: from hospital admission to neutrophil recovery (approximately 14-21 days).
Saline and sodium bicarbonate will be provided as 500mL bottle and self administered by patients. Supply of the bottles will be recorded to assess adherence.
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Control group
Active
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Outcomes
Primary outcome [1]
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Incidence of grade 3 or 4 oral mucositis graded accordiing to WHO criteria
Oral mucositis assessment and WHO grading will be conducted daily by nurses, using the unit oral assessment sheet, as per unit standard procedure.
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Assessment method [1]
324878
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Timepoint [1]
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Anytime after hospital admission until neutrophil recovery. The outcome will be assessed every day.
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Secondary outcome [1]
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Duration of WHO grade 3-4 oral mucositis
Oral mucositis will be graded daily using unit standard oral assessment sheet. Number of days with grade 3-4 will be calculated.
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Assessment method [1]
386068
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Timepoint [1]
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Anytime after hospital admission until neutrophil recovery. The outcome will be assessed every day.
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Secondary outcome [2]
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Incidence of WHO grade 2-4 oral mucositis
Oral mucositis assessment and WHO grading will be conducted daily by nurses, using the unit oral assessment sheet, as per unit standard procedure.
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Assessment method [2]
386070
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Timepoint [2]
386070
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Anytime after hospital admission until neutrophil recovery. The outcome will be assessed every day.
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Secondary outcome [3]
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Duration of WHO grade 2-4 oral mucositis
Oral mucositis will be graded daily using unit standard oral assessment sheet. Number of days with grade 2-4 will be calculated.
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Assessment method [3]
386071
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Timepoint [3]
386071
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Anytime after hospital admission until neutrophil recovery. The outcome will be assessed every day.
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Secondary outcome [4]
386072
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Incidence of taste disturbance
Patients will be asked by nurses if they have taste disturbance every day as per standard unit procedure.
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Assessment method [4]
386072
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Timepoint [4]
386072
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Anytime after hospital admission until neutrophil recovery. The outcome will be assessed every day.
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Secondary outcome [5]
386073
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Patient reported oral soreness and swallowing difficulty due to the soreness. It is a composite secondary outcome. Patient reported outcome is assessed using oral mucositis daily questionnaire (OMDQ). Patients will be asked to fill the questionnaire every day from admission until neutrophil recovery
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Assessment method [5]
386073
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Timepoint [5]
386073
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Anytime after hospital admission until neutrophil recovery. The outcome will be assessed every day.
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Secondary outcome [6]
386074
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The use of nutrition supplement. The use of enteral feeding or total parenteral nutrition will be collected from patient medical record
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Assessment method [6]
386074
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Timepoint [6]
386074
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Anytime after hospital admission until neutrophil recovery.
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Secondary outcome [7]
386075
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Opioid usage will be collected from patient medical records. It will be converted to intravenous morphine equivalence.
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Assessment method [7]
386075
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Timepoint [7]
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Anytime after hospital admission until neutrophil recovery.
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Secondary outcome [8]
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Adverse reaction (short term)
As this is a mouthwash and not ingested, adverse reaction is unlikely. When suspected or probable adverse reaction, it will be graded using CTCAE v5.0. The adverse reactions collected will be diarrhoea, constipation, nausea, vomiting, fever, rash, local irritation and other (to be specified).
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Assessment method [8]
386076
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Timepoint [8]
386076
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Anytime during intervention is given, which is anytime after hospital admission until neutrophil recovery. The outcome will be assessed every day.
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Secondary outcome [9]
387711
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Duration of taste disturbance
Patients will be asked by nurses if they have taste disturbance every day as per standard unit procedure. Number of days with taste disturbance will be calculated
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Assessment method [9]
387711
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Timepoint [9]
387711
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anytime from admission until neutrophil recovery
The outcome will be assessed every day.
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Secondary outcome [10]
387712
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Patient's acceptance for mouthwashes
Patient feedback will be collected using 11 point scale.
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Assessment method [10]
387712
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Timepoint [10]
387712
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Data will be collected on the first day of mouthwash treatment, days 5 and 10 post transplantation.
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Secondary outcome [11]
387714
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Use of patient controlled analgesia (PCA). It will be collected from patient medical record.
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Assessment method [11]
387714
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Timepoint [11]
387714
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Anytime from hospital admission until neutrophil recovery
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Eligibility
Key inclusion criteria
Eligible patients are those who receive high dose chemotherapy with or without total body irradiation (TBI) followed by autologous or allogeneic HSCT. Patients receiving myeloablative regimens, fludarabine/melphalan, BEAM, high dose melphalan and other regimens with similar oral mucositis risks will be included.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients who have oral mucositis prior to HSCT
Patients with low risk of developing oral mucositis (e.g. CAR-T cells, Donor lymphocyte infusion)
Patients who are planned to be transfer or discharge from the hospital before neutrophil recovery.
Patients who require a translator
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation software (REDCap)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified block randomisation using online software (Robust Randomisation App: https://clinicalresearch-apps.com/RRApp.html)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Sample size (54 each arm) was calculated based on the assumption that grade 3-4 OM will be reduced from 47% (control arm) to 20%, using 80% power and two-sided significance level of 5 %.
The effectiveness of the intervention will be evaluated by an intention-to-treat analysis of all patients who are randomised, irrespective of the duration of study drug administration. The primary outcome will be analysed using the chi square test or Fisher’s exact test. A p-value < 0.05 will be considered evidence of a significant difference in the primary outcome.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
31/01/2021
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Actual
20/02/2021
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Date of last participant enrolment
Anticipated
1/08/2022
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Actual
1/07/2022
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Date of last data collection
Anticipated
30/09/2022
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Actual
8/08/2022
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Sample size
Target
108
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Accrual to date
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Final
108
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
17307
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Royal Brisbane & Womens Hospital - Herston
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Recruitment postcode(s) [1]
31033
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4029 - Herston
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Funding & Sponsors
Funding source category [1]
306532
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Charities/Societies/Foundations
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Name [1]
306532
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RBWH Foundation
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Address [1]
306532
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Block 20, Central Drive, Royal Brisbane and Women's Hospital,
Butterfield Street,
Herston, Qld 4006
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Country [1]
306532
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Australia
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Primary sponsor type
Hospital
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Name
Royal Brisbane and Women's Hospital
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Address
Royal Brisbane and Women's Hospital,
Butterfield Street,
Herston, Qld 4006
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Country
Australia
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Secondary sponsor category [1]
307061
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University
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Name [1]
307061
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The University of Queensland
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Address [1]
307061
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The University of Queensland,
Brisbane QLD 4072
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Country [1]
307061
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306728
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Royal Brisbane and Women’s Hospital HREC
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Ethics committee address [1]
306728
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Human Research Ethics Office Lower ground floor, Executive Offices James Mayne Building Butterfield Street HERSTON QLD 4029
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Ethics committee country [1]
306728
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Australia
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Date submitted for ethics approval [1]
306728
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31/08/2020
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Approval date [1]
306728
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04/11/2020
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Ethics approval number [1]
306728
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HREC/2020/QRBW/68154
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Ethics committee name [2]
307083
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University of Queensland HREC
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Ethics committee address [2]
307083
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Office of Research Ethics The University of Queensland Brisbane Qld 4072 Australia
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Ethics committee country [2]
307083
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Australia
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Date submitted for ethics approval [2]
307083
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06/11/2020
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Approval date [2]
307083
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Ethics approval number [2]
307083
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Summary
Brief summary
This study will investigate the effect of topical polaprezinc mouthwash on the incidence of oral mucositis in cancer patients undergoing haematopoietic stem cell transplantation Who is it for? You may be eligible to join this study if you are aged 18 and above, have been diagnosed with blood cancer and will receive high dose chemotherapy with or without total body irradiation (TBI) followed by autologous or allogeneic haematopoietic stem cell transplantation Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive polaprezinc mouthwash 4 times daily from hospital admission until neutrophil recovery (approximately 20 days). Participants in the other group will receive sodium bicarbonate mouthwash 4 times daily from hospital admission until neutrophil recovery (approximately 20 days). Daily oral assessment will be conducted by nurses and oral mucositis severity will be graded according to the WHO mucositis scale. Patients will be asked to complete an oral mucositis daily questionnaire that evaluates their oral pain and functional difficulties. Patients’ compliance, acceptability of the mouthwashes, total opioid and patient controlled analgesia (PCA) use, enteral nutrition (EN) and total parenteral nutrition (TPN) use will be collected. If polaprezinc lower the incidence and severity of oral mucositis, it may be used in the future as an effective, inexpensive and safe prevention of oral mucositis.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Midori Nakagaki
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Address
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Cancer Care Pharmacy, Level 4 Joyce Tweddell Building,
Royal Brisbane and Women's Hospital,
Butterfield Street, Herston, Qld 4029
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Country
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Australia
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Phone
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+61 7 36470185
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Fax
104814
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Email
104814
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[email protected]
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Contact person for public queries
Name
104815
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Midori Nakagaki
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Address
104815
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Cancer Care Pharmacy, Level 4 Joyce Tweddell Building,
Royal Brisbane and Women's Hospital,
Butterfield Street, Herston, Qld 4029
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Country
104815
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Australia
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Phone
104815
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+61 7 36470185
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Fax
104815
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Email
104815
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[email protected]
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Contact person for scientific queries
Name
104816
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Midori Nakagaki
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Address
104816
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Cancer Care Pharmacy, Level 4 Joyce Tweddell Building,
Royal Brisbane and Women's Hospital,
Butterfield Street, Herston, Qld 4029
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Country
104816
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Australia
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Phone
104816
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+61 7 36470185
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Fax
104816
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Email
104816
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual participant data that underlie the results reported in this article, after deidentification
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When will data be available (start and end dates)?
Beginning 6 months and ending 5 years following article publication
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Available to whom?
Investigators whose proposed use of the data has been approved by the HREC approved this study
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Available for what types of analyses?
For review of this study and meta-analysis
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How or where can data be obtained?
Proposal should be directed to the RBWH HREC for approval. When approved, the principal investigator can be contacted by email (
[email protected]
) to obtain the data directly.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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