Circadian Disturbances After Breast Cancer Surgery

Breast Cancer Clinical Trial

— CIRCA  

Official title:

Circadian Disturbances After Breast Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01171508
• Other study ID #: MVH-02
• Status: Completed
• Phase: N/A
• First received: July 26, 2010
• Last updated: March 7, 2013
• Start date: February 2011
• Est. completion date: November 2011

Study information

• Verified date: March 2013
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Comittee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety
• Breast Cancer
• Breast Neoplasms
• Chronobiology Disorders
• Circadian Rhythm Disorders

Intervention

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.
• 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).
• 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.
• 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.
• Sleep-diary
Sleep-diary to measure subjective sleep quantity will be completed every morning and after every nap in the day.

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Melissa Voigt Hansen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative sleep architecture of breast cancer patients	Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings).	1 day preoperatively	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No