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Trial registered on ANZCTR


Registration number
ACTRN12608000253303
Ethics application status
Approved
Date submitted
16/05/2008
Date registered
19/05/2008
Date last updated
15/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to establish whether further study of sertraline in relieving severe breathlessness is warranted.
Scientific title
A phase II, double-blind, multi-site randomised controlled pilot study of sertraline compared with placebo in relieving refractory breathlessness.
Secondary ID [1] 288163 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Sertraline for dyspnoea
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intractable dyspnoea 3156 0
Condition category
Condition code
Respiratory 3313 3313 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sertraline 25-100mg mane via oral capsule.
Days 1-3 Sertrlaine 25mg, Days 4-6, sertraline 50mg mane, Days 7-28 sertraline 100mg mane. Dose modification is included in the protocol. After the 28 day intervention period the dose is titrated downwards with the mediaction ceasing after day 34, or, participant can remain on medication until the end of the pilot study if experiencing benefit from the medication.
Intervention code [1] 2889 0
Treatment: Drugs
Comparator / control treatment
Corn starch placebo capsule
Control group
Placebo

Outcomes
Primary outcome [1] 4205 0
Change in numerical rating scale of average morning and average evening breathlessness in the last 3 days of treatment (d26, d27, d28) compared with baseline, with a comparison between treatment groups.
Timepoint [1] 4205 0
Data from days 26, 27 & 28
Secondary outcome [1] 7106 0
Differences in anxiety and depression sub-scales on the Hospital Anxiety and Depression Scale (HADS) between the two groups at the end of the study
Timepoint [1] 7106 0
Day 28
Secondary outcome [2] 7107 0
Differences between rates of falls in the 2 trreatment groups
Timepoint [2] 7107 0
Throughout study period. Participants are asked about falls at each Study Nurse contact on Days 3, 6, 9, 14, 21 and 28.
Secondary outcome [3] 7108 0
Differences in nausea, diarrhoea, insomnia, somnolence, dizziness, tremour, agitation and restlessness
Timepoint [3] 7108 0
Throughout study period. Participants are asked about the listed side effects at each Study Nurse contact on Days 3, 6, 9, 14, 21 and 28.
Secondary outcome [4] 7109 0
Differences in quality of life between the two groups at conclusion of the study using the "European Organisation for Research and Treatment of Cancer (EORTC) 30" quality of life questionnaire
Timepoint [4] 7109 0
Day 28
Secondary outcome [5] 7110 0
Differences in worst and best dyspnoea scores averaged across the last three days of the study
Timepoint [5] 7110 0
Data from days 26, 27 and 28
Secondary outcome [6] 7111 0
Rate of withdrawal
Timepoint [6] 7111 0
Throughout study period. Participants are asked about withdrawal criteria at each Study Nurse contact on Days 3, 6, 9, 14, 21 and 28 and also, participants or their clinicians may contact Study Nurses and withdraw on any other days during the study.
Secondary outcome [7] 7112 0
Global impression of change for therapy
Timepoint [7] 7112 0
Day 28

Eligibility
Key inclusion criteria
18 years of age or older
Intractable dyspnoea where the underlying cause has been maximally treated.
Dyspnoea at rest or with minimal exertion, as measured by a score of = 3 on the standard Medical Research Council categorical dyspnoea exertion scale.
On stable medications over the prior week Prognosis of at least 2 months
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current therapy with any one of the listed medications which involve a risk of serotonin syndrome or potentially significant drug-drug interactions.
Cognitive impairment with Folstein Mini-mental Status Exam <24/30.
Active respiratory or cardiac event in the previous 1 week.
Medical history of severe hepatic impairment
Medical history of gastro-intestinal bleeding.
Serum sodium less than 128mmol/l
Recent difficulty with seizure control
Inability to give informed consent.

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)
On notification of a participant, the Clinical Trials Pharmacist at the Central Registry will allocate the next code available according to the supplied schedule and will advise the particular site’s Clinical Trials Pharmacist which kit (sertraline or placebo) is to be supplied to the participant. The participant ID, allocation code, dates of request, preparation, and dispensing will be recorded in a log maintained by the Central Registry and supplied to the central registry on completion of each randomisation. Each bottle containing capsules which is supplied to the participant will be labeled ‘sertraline / placebo study 25-100mg daily’
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation schedules have been developed by an organisation not involved in this study. Treatment for each participant will be allocated according to a block randomisation schedule, held by the Central Registry Clinical trials Pharmacist, in a 1:1 ratio for each treatment arm. Block randomisation will ensure even allocation to each code.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
Recruitment hospital [1] 4967 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 12459 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 3388 0
Self funded/Unfunded
Name [1] 3388 0
Southern Adelaide palliative Service
Address [1] 3388 0
700 Goodwood Road
Daw Park, SA 5041
Country [1] 3388 0
Australia
Primary sponsor type
Hospital
Name
Repatriation General Hospital
Address
Daws Road
Daw Park, SA 5041
Country
Australia
Secondary sponsor category [1] 3033 0
None
Name [1] 3033 0
Address [1] 3033 0
Country [1] 3033 0
Other collaborator category [1] 290 0
Hospital
Name [1] 290 0
Flinders Medical Centre
Address [1] 290 0
Flinders Drive
Bedford Park, SA 5042
Country [1] 290 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5420 0
Repatriation General Hospital Research and Ethics Committee
Ethics committee address [1] 5420 0
Daws Road
Daw Park, SA 5041
Ethics committee country [1] 5420 0
Australia
Date submitted for ethics approval [1] 5420 0
Approval date [1] 5420 0
15/07/2008
Ethics approval number [1] 5420 0

Summary
Brief summary
Breathlessness continues to be a major clinical problem for many people with advanced progressive illnesses such as cancer, end-stage cardiac failure or chronic obstructive pulmonary disease, even when they are receiving the best treatment for the underlying disease. Although there are some interventions that may offer benefit (oxygen therapy, sustained release low dose morphine), there is still a need for a wider range .of interventions to meet the needs of people with refractory breathlessness.

Study design: This is a phase II (pilot) double blind randomised controlled multi-site study of sertraline (titrated to a mid-range dose) or placebo. It will run for 28 days and draw participants from across the services participating.

Objectives: To establish feasibility of the study design and inform adequate power calculations for a definitive study of this intervention in the same sites in mid 2008.
Trial website
Trial related presentations / publications
Not applicable this pilot has not been unblinded
Public notes

Contacts
Principal investigator
Name 28593 0
Prof David Currow
Address 28593 0
Southern Adelaide Palliative Services 700 Goodwood Road Daw Park, SA 5041
Country 28593 0
Australia
Phone 28593 0
+61 08 8275 1732
Fax 28593 0
+61 08 8275 1201
Email 28593 0
david.currow@health.sa.gov.au
Contact person for public queries
Name 11750 0
Prof Professor David Currow
Address 11750 0
Southern Adelaide Palliative Services
700 Goodwood Road
Daw Park, SA 5041
Country 11750 0
Australia
Phone 11750 0
+61 08 8275 1732
Fax 11750 0
+61 08 8275 1201
Email 11750 0
david.currow@health.sa.gov.au
Contact person for scientific queries
Name 2678 0
Prof Professor David Currow
Address 2678 0
Southern Adelaide Palliative Services
700 Goodwood Road
Daw Park, SA 5041
Country 2678 0
Australia
Phone 2678 0
+61 08 8275 1732
Fax 2678 0
+61 08 8275 1201
Email 2678 0
david.currow@health.sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary