Circadian Rhythm DisordersCIRCANCT01171508
Circadian Disturbances After Breast Cancer Surgery
An observational study of Circadian Rhythm Disorders and Anxiety, run by Melissa Voigt Hansen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Circadian Rhythm Disorders, Anxiety, Breast Cancer
- What is being tested?
- Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USA, Polysomnograph - Embla A10 (Medcare, Reykjavik, Iceland) and Holter monitor - Medilog AR12 (Oxford Instruments, Oxford, England)
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Department of Breast Surgery at Herlev University Hospital in Copenhagen
Who may be able to join
- women, age 30-70, with breast cancer who are admitted for a lumpectomy at Herlev Hospital
- ASA score I-III
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Circadian Rhythm Disorders, Anxiety, Breast Cancer
- Being tested
- Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USA, Polysomnograph - Embla A10 (Medcare, Reykjavik, Iceland), Holter monitor - Medilog AR12 (Oxford Instruments, Oxford, England), Urine 6-sulphatoxymelatonin (aMT6s), Karolinska Sleepiness Scale
- Keywords
- Circadian Rhythm Disorders, Breast Neoplasms Surgery, Sleep, Heart Rate
- Medical subject headings
- Chronobiology Disorders, Anxiety Disorders, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USADevice
Wrist-Actigraph to be worn on the non-dominant arm on day 0-3-17 of the study.
Polysomnograph - Embla A10 (Medcare, Reykjavik, Iceland)Device
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)Device
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.
Urine 6-sulphatoxymelatonin (aMT6s)Procedure or surgery
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.
Karolinska Sleepiness ScaleOther
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 painOther
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-diaryOther
Sleep-diary to measure subjective sleep quantity will be completed every morning and after every nap in the day.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients | 12 breast cancer patients aged 30-70 years undergoing a lumpectomy at Herlev Hospital. ASA score I-III. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative sleep architecture of breast cancer patients
Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings).
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 day preoperatively till 14 days postoperatively
Secondary outcomes (3)
Preoperative heart-rate variability of breast cancer patients
Heart-rate variability measured by Holter monitor and a following analysis of frequency domain parameters.
Measured: 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.
Measured: 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.
Measured: The 14th postoperative night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startFeb 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian Rhythm DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melissa Voigt Hansen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melissa Voigt Hansen, Herlev Hospital
- Investigators
- Melissa V Hansen, MD, Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171508
- Sponsor's protocol ID
- MVH-02
- Acronym
- CIRCA
- Status last verified
- Mar 2013
- First submitted
- 26 Jul 2010
- Last updated
- 8 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Disturbances After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT01171508
- Acronym / sponsor ID
- CIRCA / MVH-02
- Conditions
- Circadian Rhythm Disorders, Anxiety, Breast Cancer
- Keywords
- Circadian Rhythm Disorders, Breast Neoplasms Surgery, Sleep, Heart Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Melissa Voigt HansenUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 28 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients | – | 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-diary12 breast cancer patients aged 30-70 years undergoing a lumpectomy at Herlev Hospital. ASA score I-III. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Department of Breast Surgery at Herlev University Hospital in Copenhagen
Key inclusion criteria (2 listed)
- women, age 30-70, with breast cancer who are admitted for a lumpectomy at Herlev Hospital
- ASA score I-III
Key exclusion criteria (15 listed)
- Known sleep apnea
- Pre-operative treatment with beta-blockers
- Diabetes Mellitus
- Known pre-operative depressive illness or dementia
- Previous or current cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USAWrist-Actigraph to be worn on the non-dominant arm on day 0-3-17 of the study. | Device | Breast cancer patients |
| 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 | Breast cancer patients |
| 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. | Device | Breast cancer patients |
| 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. | Procedure or surgery | Breast cancer patients |
| Karolinska Sleepiness ScaleKarolinska Sleepiness Scale to measure sleepiness will be filled out twice a day every day of the entire study period of 17 days. | Other | Breast cancer patients |
| Visual Analog Scale and 10 point-scales to measure fatigue, general well-being, subjective sleep and painVisual 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 | Breast cancer patients |
| Sleep-diarySleep-diary to measure subjective sleep quantity will be completed every morning and after every nap in the day. | Other | Breast cancer patients |
Primary outcome
Preoperative sleep architecture of breast cancer patients
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Preoperative heart-rate variability of breast cancer patients
Time frame: 1 day preoperatively
Postoperative heart-rate variability of breast cancer patients (early phase)
Time frame: The first postoperative night
Postoperative heart-rate variability of breast cancer patients (late phase)
Time frame: The 14th postoperative night
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa V Hansen, MD principal investigator
Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circadian Rhythm Disorders and Anxiety, run by Melissa Voigt Hansen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative sleep architecture of breast cancer patients (time frame: 1 day preoperatively). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2013.