Circadian Disturbances After Breast Cancer Surgery (CIRCA)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Anxiety; Circadian Rhythm Disorders
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2730
    • Herlev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Department of Breast Surgery at Herlev University Hospital in Copenhagen

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Breast cancer patients; 12 breast cancer patients aged 30-70 years undergoing a lumpectomy at Herlev Hospital. ASA score I-III.

Device: 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.; Device: 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).; Device: 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.; Procedure: 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.; Other: 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.; Other: 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.; Other: Sleep-diary; Sleep-diary to measure subjective sleep quantity will be completed every morning and after every nap in the day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Melissa Voigt Hansen
• Investigators: Principal Investigator: Melissa V Hansen, MD, Herlev Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: July 27, 2010
• First Posted (Estimate): July 28, 2010

Study Record Updates

• Last Update Posted (Estimate): March 8, 2013
• Last Update Submitted That Met QC Criteria: March 7, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Sleep; Heart Rate; Circadian Rhythm Disorders; Breast Neoplasms Surgery
• Additional Relevant MeSH Terms: Nervous System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Chronobiology Disorders
• Other Study ID Numbers: MVH-02