Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
12 participants
OBSERVATIONAL
2011-02-28
2011-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Breast cancer patients
12 breast cancer patients aged 30-70 years undergoing a lumpectomy at Herlev Hospital. ASA score I-III.
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.
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).
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.
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.
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.
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.
Sleep-diary
Sleep-diary to measure subjective sleep quantity will be completed every morning and after every nap in the day.
Interventions
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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.
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).
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.
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.
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.
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.
Sleep-diary
Sleep-diary to measure subjective sleep quantity will be completed every morning and after every nap in the day.
Eligibility Criteria
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Inclusion Criteria
* ASA score I-III
Exclusion Criteria
* Pre-operative treatment with beta-blockers
* Diabetes Mellitus
* Known pre-operative depressive illness or dementia
* Previous or current cancer
* Known medically treated sleep-disorder (insomnia, restless legs etc)
* Shift-work
* Daily alcohol intake of more than 5 units
* Pre-operative treatment with psychopharmacological drugs, opioids or anxiolytics (including all sleeping pills)
* Predicted bad compliance
* Pregnant or breast-feeding
* Pre- or post-operative complications or events which are expected to increase morbidity or pain the first post-operative days.
* Missing written consent
* Pre-operative MMSE score less than 24
* Urine or fecal incontinence
30 Years
70 Years
FEMALE
No
Sponsors
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Melissa Voigt Hansen
OTHER
Responsible Party
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Melissa Voigt Hansen
M.D. ph.D student
Principal Investigators
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Melissa V Hansen, MD
Role: PRINCIPAL_INVESTIGATOR
Herlev Hospital
Locations
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Herlev Hospital
Copenhagen, , Denmark
Countries
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Other Identifiers
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MVH-02
Identifier Type: -
Identifier Source: org_study_id
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