Study protocol: a phase III randomised, double-blind, parallel arm, stratified, block randomised, placebo-controlled trial investigating the clinical effect and cost-effectiveness of sertraline for the palliative relief of breathlessness in people with chronic breathlessness
Watts, Gareth J
Agar, Meera Ruth
Abernethy, Amy Pickar
Currow, David Christopher
Palliative Care Clinical Studies Collaborative (PaCCSC)
MetadataShow full item record
Introduction Breathlessness remains a highly prevalent and distressing symptom for many patients with progressive life-limiting illnesses. Evidence-based interventions for chronic breathlessness are limited, and there is an ongoing need for high-quality research into developing management strategies for optimal palliation of this complex symptom. Previous studies have suggested that selective serotonin reuptake inhibitors such as sertraline may have a role in reducing breathlessness. This paper presents the protocol for a large, adequately powered randomised study evaluating the use of sertraline for chronic breathlessness in people with progressive life-limiting illnesses. Methods and analysis A total of 240 participants with modified Medical Research Council Dyspnoea Scale breathlessness of level 2 or higher will be randomised to receive either sertraline or placebo for 28 days in this multisite, double-blind study. The dose will be titrated up every 3 days to a maximum of 100 mg daily. The primary outcome will be to compare the efficacy of sertraline with placebo in relieving the intensity of worst breathlessness as assessed by a 0–100 mm Visual Analogue Scale. A number of other outcome measures and descriptors of breathlessness as well as caregiver assessments will also be recorded to ensure adequate analysis of participant breathlessness and to allow an economic analysis to be performed. Participants will also be given the option of continuing blinded treatment until either study data collection is complete or net benefit ceases. Appropriate statistical analysis of primary and secondary outcomes will be used to describe the wealth of data obtained. Ethics and dissemination Ethics approval was obtained at all participating sites. Results of the study will be submitted for publication in peer-reviewed journals and the key findings presented at national and international conferences. Trial registration number ACTRN12610000464066.
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Showing items related by title, author, creator and subject.
A pragmatic, phase III, multisite, double-blind, placebo-controlled, parallel-arm, dose increment randomised trial of regular, low-dose extended-release morphine for chronic breathlessness: Breathlessness, Exertion And Morphine Sulfate (BEAMS) study protocol Currow, David Christopher; Watts, Gareth J; Johnson, Miriam J; McDonald, Christine; Miners, John Oliver; Somogyi, Andrew A; Denehy, Linda; McCaffrey, Nicola; Eckert, Danny J; McCloud, Philip; Louw, Sandra; Lam, Lawrence; Greene, Aine; Fazekas, Belinda Susan; Clark, Katherine; Fong, Kwun; Agar, Meera Ruth; Joshi, Rohit; Kilbreath, Sharon; Ferreira, Diana; Ekstrom, Magnus; Palliative Care Clinical Studies Collaborative (PaCCSC) (BMJ Publishing Group, 2017-07-01)Introduction Chronic breathlessness is highly prevalent and distressing to patients and families. No medication is registered for its symptomatic reduction. The strongest evidence is for regular, low-dose, extended- release ...
Researching breathlessness in palliative care: consensus statement of the National Cancer Research Institute Palliative Care Breathlessness Subgroup Peel, T; Moosavi, S; Dorman, Saskie; Jolley, C; Abernethy, Amy Pickar; Currow, David Christopher; Byrne, A; Farquhar, M; Higginson, I; Booth, Sara; Alloway, L; Bausewein, C; Wilcock, A; Johnson, M; Griffiths, G (2009)
Caregivers' Perspectives on the Use of Long-Term Oxygen Therapy for the Treatment of Refractory Breathlessness: A Qualitative Study Collier, Aileen; Breaden, Katrina Margaret; Phillips, Jane L; Agar, Meera Ruth; Litster, Caroline; Currow, David Christopher (Elsevier, 2016-11-11)Context Despite limited clinical evidence, long-term oxygen therapy (LTOT) is used for the management of refractory breathlessness in people with life-limiting illnesses who are not necessarily hypoxemic. Objectives The ...