NCT01171508

Circadian Disturbances After Breast Cancer Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: Melissa Voigt Hansen · Academic / Other
• Sex: Female
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Circadian Rhythm Disorders
• Anxiety
• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USA	Wrist-Actigraph to be worn on the non-dominant arm on day 0-3-17 of the study.
DEVICE	Polysomnograph - Embla A10 (Medcare, Reykjavik, Iceland)	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).
DEVICE	Holter monitor - Medilog AR12 (Oxford Instruments, Oxford, England)	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.
PROCEDURE	Urine 6-sulphatoxymelatonin (aMT6s)	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.
OTHER	Karolinska Sleepiness Scale	Karolinska Sleepiness Scale to measure sleepiness will be filled out twice a day every day of the entire study period of 17 days.
OTHER	Visual Analog Scale and 10 point-scales to measure fatigue, general well-being, subjective sleep and pain	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.
OTHER	Sleep-diary	Sleep-diary to measure subjective sleep quantity will be completed every morning and after every nap in the day.

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-07-28
• Last updated: 2013-03-08

Locations

1 site across 1 country: Denmark