Circadian Rhythm Disorders, Anxiety, Breast Cancer
Conditions
Keywords
Circadian Rhythm Disorders, Breast Neoplasms Surgery, Sleep, Heart Rate
Brief 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.
Interventions
DEVICEWrist-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.
DEVICEPolysomnograph - 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).
DEVICEHolter 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.
PROCEDUREUrine 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 to measure sleepiness will be filled out twice a day every day of the entire study period of 17 days.
OTHERVisual 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.
OTHERSleep-diary
Sleep-diary to measure subjective sleep quantity will be completed every morning and after every nap in the day.
Sponsors
Melissa Voigt Hansen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* women, age 30-70, with breast cancer who are admitted for a lumpectomy at Herlev Hospital * ASA score I-III
Exclusion criteria
* Known sleep apnea * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep architecture | 1 day preoperatively till 14 days postoperatively | 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. |
| Preoperative melatonin levels and amplitude | 1 day preoperatively | Excretion of aMT6s in urine. Urine will be collected from 23-07, quantified and 2 samples will be taken to measure aMT6s. |
| Postoperative melatonin levels and amplitude (early phase) | The first postoperative night | Excretion of aMT6s in urine. Urine will be collected from 23-07, quantified and 2 samples will be taken to measure aMT6s. |
| Postoperative melatonin levels and amplitude | The 14th postoperative night | Excretion of aMT6s in urine. Urine will be collected from 23-07, quantified and 2 samples will be taken to measure aMT6s. |
| Preoperative sleep architecture of breast cancer patients | 1 day preoperatively | Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings). |
| Postoperative sleep architecture of breast cancer patients (early phase) | The first postoperative night | Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings) |
| Postoperative sleep architecture of breast cancer patients (late phase) | The 14th postoperative night | Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings) |
| Sleep quality, fatigue, well-being and pain. | 1 day preoperatively till 14 days postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative heart-rate variability of breast cancer patients (early phase) | The first postoperative night | Heart-rate variability measured by Holter monitor and a following analysis of frequency domain parameters. |
| Postoperative heart-rate variability of breast cancer patients (late phase) | The 14th postoperative night | Heart-rate variability measured by Holter monitor and a following analysis of frequency domain parameters. |
| Preoperative heart-rate variability of breast cancer patients | 1 day preoperatively | Heart-rate variability measured by Holter monitor and a following analysis of frequency domain parameters. |
Countries
Denmark
Outcome results
None listed