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Trial registered on ANZCTR
Registration number
ACTRN12625000917437
Ethics application status
Approved
Date submitted
13/06/2025
Date registered
22/08/2025
Date last updated
22/08/2025
Date data sharing statement initially provided
22/08/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Developing Protocol for Strengthening the Inspiratory Muscles of Cancer Patients After a Procedure to Prevent Fluid Re-Accumulating in the Chest
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Scientific title
Acceptability and Feasibility of an Individualised Inspiratory Muscle Threshold Load Training Protocol after Intervention to control Malignant Pleural Effusion (RMT-MPE)
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Secondary ID [1]
313913
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None
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Universal Trial Number (UTN)
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Trial acronym
RMT-MPE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malignant pleural effusion
336605
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Condition category
Condition code
Respiratory
333110
333110
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0
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Other respiratory disorders / diseases
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Cancer
333111
333111
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0
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Any cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A 6-week individualised respiratory muscle training (RMT) program to be completed at the participant's home. This involves participants completing 30 rapid inspired deep breaths through an assigned breathing device, repeated twice daily. The device is a Power Breathe Plus RMT device, which is an inspiratory muscle breathing trainer designed to strengthen inspiratory muscles and improve breathing stamina.
Participants will attend the study site to meet a physiotherapist on 3 occasions, allowing 60 minutes per visit. Visit 1 will be 2 weeks after the participant’s procedure and will include a test of inspiratory muscle strength, completion of questionnaires and a demonstration of how to use the device. This visit will also involve the initial breathing training session to allow this to be supervised by the physiotherapist.
Training load will commence at 40% of inspiratory muscle strength (adjusted by physiotherapist for tolerance during initial supervised training). Threshold load of Power Breathe Plus will be increased by 2.5 cms H2O up to three times per week if all of the following are met:
• Able to complete 30 rapid, deep breaths within approximately 7 minutes.
•Rating Perceived Exertion (RPE) score recorded by participant in study diary is less than 13 out of 20 (“somewhat hard”) at end of 30 breaths.
•No moderate/severe chest muscle discomfort caused by training.
Each training session will take less than 7 minutes and include 1 minute rest periods after each set of 10 breaths (3 sets in total). Participants to then complete breathing training to suit their schedule with at least 6 hours between sessions. Participants will record details about each training session in a diary. A physiotherapist or research nurse will also phone participants during the 6-week training period for monitoring purposes and to discuss comfort of completing the breathing exercises. These phone calls will be as per below:
- Twice per week during the first 2 weeks.
- Once per week during the final 4 weeks.
Visit 2 will be 2 weeks after Visit 1 and will again include a test of inspiratory muscle strength and completion of questionnaires. Another supervised breathing training session will also occur during this Visit.
Visit 3 will be 6 weeks after Visit 1 and will again include a test of inspiratory muscle strength and completion of questionnaires. The final supervised breathing training session will also occur during this Visit.
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Intervention code [1]
330504
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Treatment: Other
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Intervention code [2]
330505
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Lifestyle
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Comparator / control treatment
Usual care. Noting that no specific exercises are done as part of usual care. Patients who have symptomatic recurrence of pleural effusion may have further drainage procedures and/or talc pleurodesis.
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Control group
Active
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Outcomes
Primary outcome [1]
340649
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Feasibility of respiratory muscle training (RMT)
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Assessment method [1]
340649
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Percentage of all RMT completed as per participant study diary AND Change in training load data gained from participant study diary and calculated during physiotherapy visits.
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Timepoint [1]
340649
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Across 6 week period of completing RMT at home.
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Primary outcome [2]
340650
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Acceptability and tolerability of respiratory muscle training (RMT)
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Assessment method [2]
340650
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Satisfaction questionnaire adapted from Dettling, D. S., M. van der Schaaf, et al. (2013). "Feasibility and effectiveness of pre-operative inspiratory muscle training in patients undergoing oesophagectomy: a pilot study." Physiother Res Int 18(1): 16-26.
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Timepoint [2]
340650
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At 2 week and 6 weeks post-commencement of intervention.
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Primary outcome [3]
340651
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Safety respiratory muscle training (RMT)
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Assessment method [3]
340651
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Tracking of adverse events. Possible adverse events of respiratory muscle training include delayed onset muscle soreness of chest wall muscles, and symptoms of eustachian tube insufficiency. Adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE5.0).
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Timepoint [3]
340651
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From baseline to 26 weeks post-commencement of intervention.
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Secondary outcome [1]
444700
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Change in maximum inspiratory pressure in the respiratory muscle training (RMT) cohort.
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Assessment method [1]
444700
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Change in maximum inspiratory pressure measured via the POWERbreathe KH2 device.
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Timepoint [1]
444700
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At baseline (commencement of intervention), 2 weeks post-commencement of intervention and 6 weeks post-commencement of intervention.
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Secondary outcome [2]
444701
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Dyspnea experienced in daily life over 26 weeks in RMT participants and control participants.
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Assessment method [2]
444701
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Dyspnea-12 questionnaire
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Timepoint [2]
444701
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For RMT participants measures at commencement of intervention, 2 weeks, 6 weeks, 8 weeks, 12 weeks, 18 weeks, 26 weeks post-commencement of intervention. For control participants measures at baseline (study entry), 2 weeks, 6 weeks, 8 weeks, 12 weeks, 18 weeks, 26 weeks.
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Secondary outcome [3]
444702
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Dyspnea experienced in daily life over 26 weeks in RMT participants and control participants.
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Assessment method [3]
444702
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VAS score dyspnea
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Timepoint [3]
444702
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For RMT participants measures at commencement of intervention, 2 weeks, 6 weeks, 8 weeks, 12 weeks, 18 weeks, 26 weeks post-commencement of intervention. For control participants measures at baseline (study entry), 2 weeks, 6 weeks, 8 weeks, 12 weeks, 18 weeks, 26 weeks.
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Secondary outcome [4]
450888
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Quality of life over 26 weeks in RMT participants and control participants.
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Assessment method [4]
450888
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EQ-5D-5L questionnaire
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Timepoint [4]
450888
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For RMT participants measures at commencement of intervention, 2 weeks, 6 weeks, 8 weeks, 12 weeks, 18 weeks and 26 weeks post-commencement of intervention. For control participants measures at baseline (study entry), 2 weeks, 6 weeks, 8 weeks, 12 weeks, 18 weeks and 26 weeks.
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Secondary outcome [5]
450889
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Number of drainages of pleural fluid over 26 weeks in RMT participants and control participants.
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Assessment method [5]
450889
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Number of drainages will each be assessed independently. Drainage will also be assessed as a composite outcome over time that allows more valid comparison of the average rate of fluid drainage (total drainage volume of fluid drained averaged per week until last drainage while alive, up until 6 months EG if drains 1.2L at 4 weeks and 0.8 L at 8 weeks and 1 L at 12 weeks and dies at 4 months with no more drainage up to 6 months, this will represent 0.25 L drainage per week). Drainage will be described qualitatively via both volume and time by scatterplot, to compare the RMT and control groups.
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Timepoint [5]
450889
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For RMT participants measures from commencement of intervention to 26 weeks post-commencement of intervention. For control participants measures from at baseline (study entry) to 26 weeks post study entry.
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Secondary outcome [6]
451330
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Volume of drainages of pleural fluid over 26 weeks in RMT participants and control participants.
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Assessment method [6]
451330
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Drainage containers will have a volumetric scale included and these data will be recorded in medical records.
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Timepoint [6]
451330
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For RMT participants measures from commencement of intervention to 26 weeks post-commencement of intervention. For control participants measures from at baseline (study entry) to 26 weeks post study entry.
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Eligibility
Key inclusion criteria
•MPE (pleural biopsy or pleural fluid diagnostic of pleural malignancy, or recurrent exudative pleural effusions with no alternative cause in the setting of histocytologically proven extra-pleural cancer).
•Have received TP or IPC aiming to control symptomatic pleural effusion
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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
• Expected survival < 6 months.
• WHO performance status 3 or 4.
• Age <18 years
• Pregnant.
•Significant chest pain expected to interfere with breathing training.
•Risk of spontaneous rib fractures (e.g. rib metastasis).
•Eustachian tube insufficiency or perforated ear drum.
•Communication difficulty or neurologic disease preventing co-operation with testing.
•Visual impairment.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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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
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/09/2025
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Actual
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Date of last participant enrolment
Anticipated
30/06/2026
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Actual
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Date of last data collection
Anticipated
30/09/2026
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
27574
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The Wesley Hospital - Auchenflower
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Recruitment hospital [2]
27575
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St Andrew's War Memorial Hospital - Brisbane
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Recruitment postcode(s) [1]
43688
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4066 - Auchenflower
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Recruitment postcode(s) [2]
43689
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4000 - Brisbane
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Funding & Sponsors
Funding source category [1]
318386
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Other
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Name [1]
318386
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Wesley Research Institute
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Address [1]
318386
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Country [1]
318386
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Australia
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Primary sponsor type
Other
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Name
Wesley Research Institute
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Address
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Country
Australia
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Secondary sponsor category [1]
320788
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None
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Name [1]
320788
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Address [1]
320788
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Country [1]
320788
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317019
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UnitingCare Health Human Research Ethics Committee
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Ethics committee address [1]
317019
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http://unitingcarehealth.com.au/research-and-education/unitingcare-health-human-research-ethics-committee
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Ethics committee country [1]
317019
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Australia
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Date submitted for ethics approval [1]
317019
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02/12/2024
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Approval date [1]
317019
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20/05/2025
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Ethics approval number [1]
317019
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Summary
Brief summary
This project aims to determine whether a 6 week respiratory muscle training (RMT) program is a well-tolerated, feasible and acceptable intervention in patients with malignant pleural effusion (MPE) after undergoing respiratory procedures. Who is it for? You may be eligible for this study if you are an adult with an MPE requiring definitive intervention (talc pleurodesis or indwelling pleural catheter). Study details Participants will be given a Power Breathe Plus RMT device and receive training from physiotherapists so they know how to use this. They then commence a 6-week training program involving 30 rapid inspired deep breaths through the Power Breathe Plus RMT device, repeated twice daily. The pressure that they are breathing against will be gradually increased by the physiotherapist during regular telehealth follow-up, in an individualised manner. It is hoped that findings from this study help develop this RMT program for use in patients with MPE.
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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
139754
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Dr Luke Garske
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Address
139754
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The Wesley Hospital, 451 Coronation Drive, Auchenflower Queensland 4066
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Country
139754
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Australia
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Phone
139754
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+61 7 3193 3389
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Fax
139754
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Email
139754
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[email protected]
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Contact person for public queries
Name
139755
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Joshua Sear
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Address
139755
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Level 8, East Wing, The Wesley Hospital, 451 Coronation Drive, Auchenflower Queensland 4066
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Country
139755
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Australia
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Phone
139755
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+61 7 3721 1500
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Fax
139755
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Email
139755
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[email protected]
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Contact person for scientific queries
Name
139756
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Luke Garske
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Address
139756
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The Wesley Hospital, 451 Coronation Drive, Auchenflower Queensland 4066
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Country
139756
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Australia
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Phone
139756
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+61 7 3193 3389
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Fax
139756
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Email
139756
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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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