Circadian Disturbances After Breast Cancer Surgery
Condition: Circadian Rhythm Disorders; Anxiety; Breast Cancer
MeSH terms: Breast Neoplasms; Chronobiology Disorders
Study type: Observational

Summary: 
      The purpose of this study is to investigate circadian disturbances after breast cancer
      surgery by means of monitoring sleep and heart-rate variability, by measuring a metabolite of
      melatonin in urine and by questionnaires and a sleep-diary.
    

Detailed description: 
      An increasing number of studies have shown that circadian variation in the excretion of
      hormones, the sleep-wake cycle, the core body temperature, the tone of the autonomic nervous
      system and the activity rhythm are important both in health and disease processes. More
      attention is being paid towards the circadian variation in endogenous rhythms in relation to
      surgery and whether this can affect postoperative recovery, morbidity and mortality.

      Studies have been done on circadian disturbances after major and minor surgery but never in
      relation to breast cancer surgery.

      This study will investigate circadian disturbances in this specific group of patients by
      using Actigraphy, Polysomnography (PSG), Holter-monitoring (HRV), the primary metabolite of
      melatonin in urine 6-sulfatoxymelatonin (aMT6s), questionnaires and a sleep-diary.
    

Intervention name(s): Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USA; Polysomnograph - Embla A10 (Medcare, Reykjavik, Iceland); Holter monitor - Medilog AR12 (Oxford Instruments, Oxford, England); Urine 6-sulphatoxymelatonin (aMT6s); Karolinska Sleepiness Scale; Visual Analog Scale and 10 point-scales to measure fatigue, general well-being, subjective sleep and pain; Sleep-diary
Intervention type(s): Device; Device; Device; Procedure; Other; Other; Other
Intervention description(s): Wrist-Actigraph to be worn on the non-dominant arm on day 0-3-17 of the study.; Polysomnography on day 0-3-17 of the study. This is a portable polysomnograph with 16 digital channels for recording of electroencephalogram (EEG), electrooculograph (EOG) and electromyograph (EMG).; Holter monitoring on day 0-3-17 of the study. Measurements are done by superficial skin-electrodes placed after standardised rules from the producer of the device.; Urine sampling for measurement of the primary metabolite of melatonin - 6-sulphatoxymelatonin (aMT6s) will be done on day 0-3-17 of the study. The analysis will be done by a radioimmunoassay.; Karolinska Sleepiness Scale to measure sleepiness will be filled out twice a day every day of the entire study period of 17 days.; Visual Analog Scale and 10 point-scales to measure fatigue, general well-being, subjective sleep and pain will be filled out twice a day everyday of the study period of 17 days.; Sleep-diary to measure subjective sleep quantity will be completed every morning and after every nap in the day.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Department of Breast Surgery at Herlev University Hospital in Copenhagen
      
Biospecimen description: 
      Urine
    
Keywords: Circadian Rhythm Disorders; Breast Neoplasms Surgery; Sleep; Heart Rate