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Zopiclone Versus Placebo for Short-Term Treatment of Insomnia In Jakobsen et al. Trials (2018) 19:707 https://doi.org/10.1186/s13063-018-3088-3 STUDYPROTOCOL Open Access 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 Jakobsen1,2*, Morten Engstrøm3,4, Ørnulf Paulsen1,5, Karin Sjue6, Sunil X. Raj1,2, Morten Thronæs1,2, Marianne Jensen Hjermstad7, Stein Kaasa7, Peter Fayers8 and Pål Klepstad9,10 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. Keywords: Advanced cancer, Insomnia, Pharmacological treatment, Randomized controlled trial Background sleep disturbance was reported by 61% of the cancer pa- Sleep disturbance is frequent in patients with advanced tients [3]. This prevalence corresponds with results from cancer and might impair the tolerance of other symp- another multicenter study where 78% of the patients toms and reduce quality of life [1, 2]. An observational with advanced cancer experienced poor sleep quality [4]. study in different settings of palliative care found that Insomnia is the most prevalent sleep disorder both in the general population and among patients with cancer * Correspondence: [email protected] [5]. The prevalence of insomnia in the general popula- 1European Palliative Care Research Centre (PRC), Department of Clinical and tion, when defined according to formal diagnostic sys- Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU, Norwegian University of Science and Technology and St. Olavs hospital, tems, is approximately 10% [6, 7]. The prevalence of Trondheim University Hospital, Trondheim, Norway insomnia in patients with cancer is reported to be three- 2Cancer Clinic, St. Olavs hospital, Trondheim University Hospital, Trondheim, fold higher [8]. Insomnia in the context of cancer is Norway Full list of author information is available at the end of the article characterized as difficulty initiating sleep and/or © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Jakobsen et al. Trials (2018) 19:707 Page 2 of 9 difficulty maintaining sleep, which impairs daytime func- cancer-related sleep disturbance (insomnia and insomnia tioning [9]. syndrome) in oncology practice, and identified no RCT Sleep quality in patients with advanced cancer might data involving pharmacological interventions for insom- be influenced by several factors such as pain, fatigue, nia in advanced cancer [16]. Despite the lack of evi- and anxiety, worries about the future, little daytime ac- dence, several classes of sleep medications are used to tivity, interrupted sleep because of procedures, a large treat sleep disturbance in patients with cancer [24]. In a number of medications, and systemic inflammation [1, European multicenter study, the most frequently used 10–12]. In palliative care cancer populations, where life hypnotic drug was the non-benzodiazepine hypnotic expectancy is limited, the goal of symptom relief usually agent zopiclone, which was used by 348 of 2282 patients overrides the concerns of long-term side effects [13]. with advanced cancer [24]. Therefore, we designed a However, because of polypharmacy and advanced cancer double-blind, placebo-controlled, parallel-group RCT to disease, the patients are more vulnerable to potential evaluate the short-term effectiveness of zopiclone on short-term side effects. Thus, results from studies on self-reported sleep quality in patients with advanced pharmacological treatment for insomnia in non-cancer metastatic cancer who report insomnia. populations are not necessarily applicable to patients with advanced cancer. A careful selection of sleep medi- Methods cations that benefit advanced cancer patients is therefore The trial adheres to the Standard Protocol Items: Rec- important. ommendations for Interventional trials (SPIRIT) check- A combined step-wise pharmacological and non- list (see Additional file 1). pharmacological approach is recommended in the treat- ment of insomnia in cancer patients [14]. In cases where Study design sleep disturbance is due to the cancer or its treatment, This study is designed as a randomized, double-blind, the first step is to remove the causative condition if pos- placebo-controlled, parallel-group, multicenter, phase IV sible (e.g., pain, dyspnea, anxiety) [15]. The second step clinical trial. should include non-pharmacological sleep interventions with cognitive behavioral therapy [16]. Cognitive behav- Study objectives and endpoints ioral therapy for insomnia (CBT-I) usually consists of The primary objective is to study the short-time effect- psychoeducation/sleep hygiene, relaxation training, iveness of zopiclone on patient-reported subjective sleep stimulus control therapy, and cognitive therapy [17]. In quality in patients with advanced cancer who report in- a European guideline, CBT-I is recommended as the first somnia. The primary endpoint is patient-reported sleep line treatment for chronic insomnia in adults of any age quality during the final study night with treatment (night [18]. A randomized controlled trial (RCT) supported the 6) assessed on a numerical rating scale (NRS) of 0–10, efficacy of CBT-I for chronic insomnia associated with where 0 = Best sleep and 10 = Worst possible sleep. The cancer [19]. However, a major limitation for the routine secondary objective is to study the effectiveness of zopi- implementation of CBT-I in cancer clinics is the lack of clone on mean self-reported total sleep time and sleep mental health professionals formally trained in this ap- onset latency. Table 1 summarizes the objectives and proach. In addition, the number of CBT sessions, usually endpoints including the explorative objectives. four to eight sessions, can be too demanding for patients during cancer treatment or for patients with advanced Sample size cancer disease. Thus, when life expectancy is short, The primary variable used in the sample size calculation medication is recommended as the treatment of choice is patient-reported sleep quality on an NRS of 0–10 dur- for insomnia because of its rapid effect [20, 21]. ing night 6 (the last study night with treatment). The de- To manage insomnia successfully, pharmacological fined minimal clinical important difference (MCID) treatment for insomnia should reduce sleep latency, in- between the two study groups (zopiclone/placebo) is 2 crease sleep maintenance, and improve sleep quality for the primary outcome sleep quality, scored on the [22]. A variety of pharmacological agents against insom- NRS. Due to the lack of relevant data for MCID for NRS nia has been recommended for use in the general popu- on sleep quality, this number was chosen based upon lation, but their efficacy and safety in adults with cancer NRS in cancer pain studies [25, 26]. Data obtained in re- are not established [16]. A Cochrane Database review of cent studies suggest an expected standard deviation of clinical trials assessing the safety and efficacy of benzodi- 2.75 [27–33]. Using a significance level of 5%, these as- azepines or benzodiazepine receptor agonists in treating sumptions indicate that for 80% power 33 patients are insomnia in palliative care identified no articles that met needed in each group. For 90% power a sample size of the inclusion criteria [23]. In 2013, Howell et al. 42 per group is required. The study will aim for a 90% reviewed the evidence base for the management of power and allow for an expected number of 8 drop-outs Jakobsen et al. Trials (2018) 19:707 Page 3
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