Zopiclone versus placebo for short-term treatment of insomnia in patients with advanced cancer: study protocol for a double-blind, randomized, placebo-controlled, clinical multicenter trial
Gunnhild Jakobsen,
Morten Engstrøm,
Ørnulf Paulsen,
Karin Sjue,
Sunil X. Raj,
Morten Thronæs,
Marianne Jensen Hjermstad,
Stein Kaasa,
Peter Fayers,
Pål Klepstad
Affiliations
Gunnhild Jakobsen
European Palliative Care Research Centre (PRC), Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU, Norwegian University of Science and Technology and St. Olavs hospital, Trondheim University Hospital
Morten Engstrøm
Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology
Ørnulf Paulsen
European Palliative Care Research Centre (PRC), Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU, Norwegian University of Science and Technology and St. Olavs hospital, Trondheim University Hospital
Karin Sjue
Department of Oncology, Vestfold Hospital Trust
Sunil X. Raj
European Palliative Care Research Centre (PRC), Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU, Norwegian University of Science and Technology and St. Olavs hospital, Trondheim University Hospital
Morten Thronæs
European Palliative Care Research Centre (PRC), Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU, Norwegian University of Science and Technology and St. Olavs hospital, Trondheim University Hospital
Marianne Jensen Hjermstad
European Palliative Care Research Centre (PRC), Department of Oncology, Oslo University Hospital, and Institute of Clinical Medicine, University of Oslo
Stein Kaasa
European Palliative Care Research Centre (PRC), Department of Oncology, Oslo University Hospital, and Institute of Clinical Medicine, University of Oslo
Peter Fayers
Division of Applied Health Sciences, University of Aberdeen
Pål Klepstad
Department of Anaesthesiology and Intensive Care Medicine, St. Olavs hospital, Trondheim University Hospital
Abstract Background Despite the high prevalence of insomnia in patients with advanced cancer, there are no randomized controlled trials on pharmacological interventions for insomnia in this group of patients. A variety of pharmacological agents is recommended to manage sleep disturbance for insomnia in the general population, but their efficacy and safety in adults with advanced cancer are not established. Thus, there is a need to evaluate the effectiveness of medications for insomnia in order to improve the evidence in patients with advanced cancer. One of the most used sleep medications at present in patients with cancer is zopiclone. Methods This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. A total of 100 patients with metastatic cancer who report insomnia will be randomly allocated to zopiclone or placebo. The treatment duration with zopiclone/placebo is 6 consecutive nights. The primary endpoint is patient-reported sleep quality during the final study night (night 6) assessed on a numerical rating scale of 0–10, where 0 = Best sleep and 10 = Worst possible sleep. Secondary endpoints include the mean patient-reported total sleep time and sleep onset latency during the final study night (night 6). Discussion Results from this study on treatment of insomnia in advanced cancer will contribute to clinical decision-making and improve the treatment of sleep disturbance in this patient cohort. Trial registration ClinicalTrials.gov, NCT02807922. Registered on 21 June 2016.
