Abstract
BackgroundDespite 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.MethodsThis 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).DiscussionResults 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 registrationClinicalTrials.gov, NCT02807922. Registered on 21 June 2016.
Highlights
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
To improve palliative care, evidenced-based knowledge on the effects of therapeutic interventions is needed [47]. This randomized, double-blind, placebo-controlled, parallel-group, multicenter, clinical trial will provide important evidence concerning the short-time effectiveness of zopiclone for treatment of insomnia in palliative care
Recruiting patients with metastatic cancer is a major challenge, and research that involves patients with advanced cancer creates several ethical challenges. These patients are especially vulnerable and are at risk of several symptoms caused by the cancer disease and by short-time side effects of the therapy
Summary
The trial adheres to the Standard Protocol Items: Recommendations for Interventional trials (SPIRIT) checklist (see Additional file 1). Study objectives and endpoints The primary objective is to study the short-time effectiveness of zopiclone on patient-reported subjective sleep quality in patients with advanced cancer who report insomnia. The primary endpoint is patient-reported sleep quality during the final study night with treatment (night 6) assessed on a numerical rating scale (NRS) of 0–10, where 0 = Best sleep and 10 = Worst possible sleep. Sample size The primary variable used in the sample size calculation is patient-reported sleep quality on an NRS of 0–10 during night 6 (the last study night with treatment). The defined minimal clinical important difference (MCID) between the two study groups (zopiclone/placebo) is 2 for the primary outcome sleep quality, scored on the NRS. The study will aim for a 90% power and allow for an expected number of 8 drop-outs
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