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 Hansen, Michael Tvilling Madsen, Ida Hageman, Lars Simon Rasmussen, Susanne Bokmand, Jacob Rosenberg, Ismail Gögenur

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    Abstrakt

    Introduction: Breast cancer represents about onethird 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 doubleblind, 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, wellbeing 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.

    OriginalsprogEngelsk
    Artikelnummere000647
    TidsskriftBMJ Open
    Vol/bind2
    Udgave nummer1
    DOI
    StatusUdgivet - 2 apr. 2012

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