Circadian Disturbances After Breast Cancer Surgery

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.

Conditions

• Circadian Rhythm Disorders
• Anxiety
• Breast Cancer

Interventions

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.

Sponsors & Collaborators

• Melissa Voigt Hansen

  lead OTHER

Principal Investigators

• Melissa V Hansen, MD · Herlev Hospital

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-02-28

Primary Completion

2011-11-30

Completion

2011-11-30

Countries

• Denmark

Study Locations