Circadian Disturbances After Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Sleep quality, fatigue, well-being and pain.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women, age 30-70, with breast cancer who are admitted for a lumpectomy at Herlev Hospital
- •ASA score I-III
排除标准
- •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
结局指标
主要结局
Sleep quality, fatigue, well-being and pain.
时间窗: 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.
Postoperative sleep architecture of breast cancer patients (early phase)
时间窗: 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)
时间窗: The 14th postoperative night
Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings)
Preoperative sleep architecture of breast cancer patients
时间窗: 1 day preoperatively
Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings).
Postoperative melatonin levels and amplitude
时间窗: 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.
Sleep architecture
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- Preoperative heart-rate variability of breast cancer patients(1 day preoperatively)
- Postoperative heart-rate variability of breast cancer patients (early phase)(The first postoperative night)
- Postoperative heart-rate variability of breast cancer patients (late phase)(The 14th postoperative night)
研究者
Melissa Voigt Hansen
M.D. ph.D student
Herlev Hospital