CIRCA: Circadian Disturbances After Breast Cancer Surgery

Sponsor

Melissa Voigt Hansen (Other)

Overall Status

Completed

CT.gov ID

NCT01171508

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Circadian Rhythm Disorders Anxiety Breast Cancer	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 Design

Study Type:

Observational

Actual Enrollment :

12 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Circadian Disturbances After Breast Cancer Surgery

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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