The effect of MELatOnin on Depression, anxietY, cognitive function and sleep disturbances in patients with breast cancer. The MELODY trial: protocol for a randomised, placebo-controlled, double-blinded trial
- Melissa Voigt Hansen1,
- Michael Tvilling Madsen1,
- Ida Hageman2,
- Lars Simon Rasmussen3,
- Susanne Bokmand4,
- Jacob Rosenberg1,
- Ismail Gögenur1
- 1Department of Surgery, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark
- 2Psychiatric Center Copenhagen, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
- 3Department of Anaesthesia, Centre of Head and Orthopaedics, University of Copenhagen, Copenhagen, Denmark
- 4Department of Breast Surgery, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark
- Correspondence to Melissa Voigt Hansen;
- Received 18 November 2011
- Accepted 19 December 2011
- Published 11 January 2012
Introduction Breast cancer represents about one-third of all cancer diagnoses and accounts for about 15% of cancer deaths in women. Many of these patients experience depression, anxiety, sleep disturbances and cognitive dysfunction. This may adversely affect quality of life and also contribute to morbidity and mortality. Melatonin is a regulatory circadian hormone having, among others, a hypnotic and an antidepressive effect. It has very low toxicity and very few adverse effects compared with the more commonly used antidepressants and hypnotics.
Methods and analysis The objective of this double-blind, randomised, placebo-controlled trial is to investigate whether treatment with oral melatonin has a prophylactic or ameliorating effect on depressive symptoms, anxiety, sleep disturbances and cognitive dysfunction in women with breast cancer. Furthermore, the authors will examine whether a specific clock-gene, PER3, is correlated with an increased risk of depressive symptoms, sleep disturbances or cognitive dysfunction. The MELODY trial is a prospective double-blinded, randomised, placebo-controlled trial in which the authors intend to include 260 patients. The primary outcome is depressive symptoms measured by the Major Depression Inventory. The secondary outcomes are anxiety measured by a Visual Analogue Scale, total sleep time, sleep efficiency, sleep latency and periods awake measured by actigraphy and changes in cognitive function measured by a neuropsychological test battery. Tertiary outcomes are fatigue, pain, well-being and sleep quality/quantity measured by Visual Analogue Scale and sleep diary and sleepiness measured by the Karolinska Sleepiness Scale. The PER3 genotype is also to be determined in blood samples.
To cite: Hansen MV, Madsen MT, Hageman I, et al. The effect of MELatOnin on Depression, anxietY, cognitive function and sleep disturbances in patients with breast cancer. The MELODY trial: protocol for a randomised, placebo-controlled, double-blinded trial. BMJ Open 2012;2:e000647. doi:10.1136/bmjopen-2011-000647
Funding This work was supported by grants from the University of Copenhagen, the Aase and Ejnar Danielsens Foundation, the A P Møller Foundation for the Advancement of Medical Science, the Else and Mogens Wedell Wedellborgs Foundation, the Beckett Foundation, the Hede Nielsen Family Foundation, the Dagmar Marshalls Foundation and Manufacturer Einar Willumsen's Memorial Scholarship. These above-mentioned funders have had no influence on the study design, will have no influence on collection, management, analysis and interpretation of data, writing of the report or the decision to submit the report for publication. All these activities are done by the authors. Pharma Nord provided the melatonin and placebo tablets but had no influence on the study design and will have no influence on the interpretation of results.
Competing interests None.
Contributors All authors have participated in making substantial contributions to conception and design, drafting the article or revising it critically for important intellectual content and all authors have approved the final version to be published.
Provenance and peer review Not commissioned; externally peer reviewed.
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