A randomised double-blind multi-site parallel arm controlled trial to assess relief of refractory breathlessness comparing oral sertraline and placebo.
Palliative Care Clinical Studies Collaborative (PaCCSC)Dataset description
Data set includes: 223 participants were included in the intention-to-treat analysis (112 receiving sertraline and 111 receiving Placebo). Treatment period over 28 days with follow-up fortnightly for 4 weeks when possible. Data available for demographic, medical history data, concurrent medications, and baseline clinical measures. Primary outcome data measured by average breathlessness on 100mm visual analogue scale and safety and toxicity data measured using the NCI CTCAE V4.0. Other data for secondary analysis include; Australia-modified Karnofsky Performance Status, spirometry., pulse oximetry, resting respiratory rate, pathology measures including full blood count, electrolyte function, renal function and serum sodium; global impression of change, blinded patient preference for symptomatic and net benefit, MRC dyspnoea scale, CRQ dyspnoae subscale, EORTC- QLQ-15 and CQOLC, measures of lifespace, HADS, breathlessness intensity and the degree to which it is unpleasant using VAS and four point Likert scales; dyspnoea scores for worst dyspnoea in the previous day measured on 0-10 NRS and a four point Likert scale; severity ranking of dyspnoea target symptoms on Likert scales; functional impairment scores on the MRC categorical scale; Healthcare utilisation including number of inpatient admissions and days spent in hospital by level of dependency (low, medium, high), home care palliative care team visits, general practitioner visits, participant preference for where they prefer to be cared for given their current health state.Date Information
Identifiers
Source Study
Trial name (public)
Purpose:
Phase:
Trial acronym
Not available
Trial ID
ACTRN12610000464066
Funding
Government body, Commonwealth Department of Health and Ageing
Scientific enquiries
Prof David Currow
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. .... Read more
Key Inclusion Criteria
Adults (age >18) Refractory dyspnoea where the underlying cause of the dyspnoea has been maximally treated. Refractory dyspnoea does not have a minimum duration and can have been present for any period of time. A medical specialist must document that all identified reversible causes of the dyspnoea are being optimally managed Breathlessness of a level 3 or higher on the Modified Medical Research Council (MRC) dyspnoea scale On stable medications for breathlessness over the prior week except rout .... Read more
Key Exclusion Criteria
1. Previous adverse reaction to sertraline 2. History of severe hepatic impairment defined as Childs Pugh Class of ‘C’ (score of 11 to 15) 3. Gastro-intestinal bleeding within the previous six months 4. Serum sodium less than 128mmol/l 5. Recent difficulty with seizure control 6. Evidence of respiratory depression with resting respiratory rate <8 7. Active respiratory or cardiac event in the previous week, not including upper respiratory tract infections. Illness must be resolved for at least 1 .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 160
Min. age 18 Years
Max. age 0 No limit
Sex Both males and females
Condition category Intractable dyspnoea
Condition code Respiratory
Intervention
Intervention code Treatment: Drugs
Sertraline/placebo 25-100mg in the morning via oral capsule. Days 1-3 Sertraline/placebo 25mg each morning, Days 4-6, sertraline/placebo 50mg each morning, Days 7-28 sertraline/placebo 100mg each morning. Dose modification is included in the protocol. After the 28 day intervention period the dose is titrated downwards with the medication ceasing after day 34, or, participant can remain on blinded medication if experiencing benefit from the medication.
Comparison
Control group Placebo
Placebo comprised of micro crystalline celllose in a gelatine capsule.
Outcomes
Outcome: Change in the current sensation of breathlessness using a 100mm Visual Analogue Scale and a 4 point likert scale.Timepoint: Assessed at baseline (morning and evening), daily in the morning and evening of days 26, 27 and 28, and at study exit. Average of morning and evening scores over the last three days (day 26, 27 and 28) will determine response.
Will the study consider sharing individual participant data?
Yes
Who can request access to individual participant data?
Other researchers who have specifically applied to the Principal Investigator and whose projects have appropriate Human Research Ethics committee approval. To be decided on a case by case basis by the Principal Investigator.
Are there any conditions for requesting access to individual participant data?
-
What individual participant data might be shared?
Individual participant data not covered above
Individual participant data that underlie the results reported in the primary publication, after de-identification (text, tables, figures and appendices). Medicare and all other administrative data will not be available.
What types of analyses could be done with individual participant data?
Data will be available for analysis to achieve the aims in the approved proposal.
Are there extra considerations when requesting access to individual participant data?
No
When can request for individual data be made (start and end dates)?
From: Data is available from the date of publication, for a period of 15 years.
To: -