Circadian Disturbances After Breast Cancer Surgery
30 Years
70 Years
Female
Circadian Rhythm Disorders, Anxiety, Breast Cancer
Trial Information
Circadian Disturbances After Breast Cancer Surgery
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Preoperative sleep architecture of breast cancer patients
Outcome Description:
Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings).
Outcome Time Frame:
1 day preoperatively
Safety Issue:
No
Principal Investigator
Melissa V Hansen, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Herlev Hospital
Authority:
Denmark: The Danish National Comittee on Biomedical Research Ethics
Study ID:
MVH-02
NCT ID:
NCT01171508
Start Date:
February 2011
Completion Date:
November 2011
Related Keywords:
- Circadian Rhythm Disorders
- Anxiety
- Breast Cancer
- Circadian Rhythm Disorders
- Breast Neoplasms Surgery
- Sleep
- Heart Rate
- Anxiety Disorders
- Breast Neoplasms
- Chronobiology Disorders
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