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.
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.
Study Type
OBSERVATIONAL
Enrollment
12
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.
Herlev Hospital
Copenhagen, Denmark
Preoperative sleep architecture of breast cancer patients
Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings).
Time frame: 1 day preoperatively
Postoperative sleep architecture of breast cancer patients (early phase)
Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings)
Time frame: The first postoperative night
Postoperative sleep architecture of breast cancer patients (late phase)
Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings)
Time frame: The 14th postoperative night
Sleep quality, fatigue, well-being and pain.
Fatigue, generel well-being, subjective sleep and pain scores on a Visual Analog Scale - questionnaires filled out daily. Sleepiness measured by Karolinska Sleepiness Scale. A sleep-diary recording sleep quantity of day and night sleep.
Time frame: 1 day preoperatively till 14 days postoperatively
Preoperative melatonin levels and amplitude
Excretion of aMT6s in urine. Urine will be collected from 23-07, quantified and 2 samples will be taken to measure aMT6s.
Time frame: 1 day preoperatively
Postoperative melatonin levels and amplitude (early phase)
Excretion of aMT6s in urine. Urine will be collected from 23-07, quantified and 2 samples will be taken to measure aMT6s.
Time frame: The first postoperative night
Postoperative melatonin levels and amplitude
Excretion of aMT6s in urine. Urine will be collected from 23-07, quantified and 2 samples will be taken to measure aMT6s.
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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.
Time frame: The 14th postoperative night
Sleep architecture
Actigraphy (total minutes asleep, sleep effectiveness, sleep latency, awakenings). A wrist actigraph wil be worn from 1 day preoperatively and taken off on the 14th postoperative day.
Time frame: 1 day preoperatively till 14 days postoperatively
Preoperative heart-rate variability of breast cancer patients
Heart-rate variability measured by Holter monitor and a following analysis of frequency domain parameters.
Time frame: 1 day preoperatively
Postoperative heart-rate variability of breast cancer patients (early phase)
Heart-rate variability measured by Holter monitor and a following analysis of frequency domain parameters.
Time frame: The first postoperative night
Postoperative heart-rate variability of breast cancer patients (late phase)
Heart-rate variability measured by Holter monitor and a following analysis of frequency domain parameters.
Time frame: The 14th postoperative night