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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast cancer patients | 12 breast cancer patients aged 30-70 years undergoing a lumpectomy at Herlev Hospital. ASA score I-III. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USA | Device | Wrist-Actigraph to be worn on the non-dominant arm on day 0-3-17 of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative sleep architecture of breast cancer patients | Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings). | 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) | 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) | 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. | 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. | 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. | The first postoperative night |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative heart-rate variability of breast cancer patients | Heart-rate variability measured by Holter monitor and a following analysis of frequency domain parameters. | 1 day preoperatively |
| Postoperative heart-rate variability of breast cancer patients (early phase) |
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Inclusion Criteria:
Exclusion Criteria:
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Department of Breast Surgery at Herlev University Hospital in Copenhagen
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| Name | Affiliation | Role |
|---|---|---|
| Melissa V Hansen, MD | Herlev Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Hospital | Copenhagen | 2730 | Denmark |
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Urine
| Polysomnograph - Embla A10 (Medcare, Reykjavik, Iceland) | Device | 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) | Device | 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) | Procedure | 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. |
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| Karolinska Sleepiness Scale | Other | Karolinska Sleepiness Scale to measure sleepiness will be filled out twice a day every day of the entire study period of 17 days. |
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| Visual Analog Scale and 10 point-scales to measure fatigue, general well-being, subjective sleep and pain | Other | 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 | Other | Sleep-diary to measure subjective sleep quantity will be completed every morning and after every nap in the day. |
|
| 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. |
| 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. | 1 day preoperatively till 14 days postoperatively |
Heart-rate variability measured by Holter monitor and a following analysis of frequency domain parameters. |
| 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. | The 14th postoperative night |
| ID | Term |
|---|---|
| D021081 | Chronobiology Disorders |
| D001008 | Anxiety Disorders |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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