None listed
Conditions
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.
Interventions
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.
Sponsors
Repatriation General Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed