Circadian Disturbances After Breast Cancer Surgery

Completed

• Conditions: Circadian Rhythm Disorders; Anxiety; Breast Cancer
• Interventions: Device: Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USA; Device: Polysomnograph - Embla A10 (Medcare, Reykjavik, Iceland); Device: Holter monitor - Medilog AR12 (Oxford Instruments, Oxford, England); Procedure: Urine 6-sulphatoxymelatonin (aMT6s); Other: Karolinska Sleepiness Scale; Other: Visual Analog Scale and 10 point-scales to measure fatigue, general well-being, subjective sleep and pain; Other: Sleep-diary

• Registration Number: NCT01171508
• Lead Sponsor: Melissa Voigt Hansen

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.

Study Timeline

• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-07-27
• Study First Posted: 2010-07-28
• Study Start: 2011-02
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-07
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer patients	Holter monitor - Medilog AR12 (Oxford Instruments, Oxford, England)	12 breast cancer patients aged 30-70 years undergoing a lumpectomy at Herlev Hospital. ASA score I-III.
Breast cancer patients	Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USA	12 breast cancer patients aged 30-70 years undergoing a lumpectomy at Herlev Hospital. ASA score I-III.
Breast cancer patients	Karolinska Sleepiness Scale	12 breast cancer patients aged 30-70 years undergoing a lumpectomy at Herlev Hospital. ASA score I-III.
Breast cancer patients	Urine 6-sulphatoxymelatonin (aMT6s)	12 breast cancer patients aged 30-70 years undergoing a lumpectomy at Herlev Hospital. ASA score I-III.
Breast cancer patients	Visual Analog Scale and 10 point-scales to measure fatigue, general well-being, subjective sleep and pain	12 breast cancer patients aged 30-70 years undergoing a lumpectomy at Herlev Hospital. ASA score I-III.
Breast cancer patients	Polysomnograph - Embla A10 (Medcare, Reykjavik, Iceland)	12 breast cancer patients aged 30-70 years undergoing a lumpectomy at Herlev Hospital. ASA score I-III.
Breast cancer patients	Sleep-diary	12 breast cancer patients aged 30-70 years undergoing a lumpectomy at Herlev Hospital. ASA score I-III.

Primary Outcome Measures

Name	Time	Method
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.
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)
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 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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Copenhagen, Denmark