Status:
COMPLETED
Circadian Disturbances After Breast Cancer Surgery
Lead Sponsor:
Melissa Voigt Hansen
Conditions:
Circadian Rhythm Disorders
Anxiety
Eligibility:
FEMALE
30-70 years
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 ...
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 acti...
Eligibility Criteria
Inclusion
- women, age 30-70, with breast cancer who are admitted for a lumpectomy at Herlev Hospital
- ASA score I-III
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01171508
Start Date
February 1 2011
End Date
November 1 2011
Last Update
March 8 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Herlev Hospital
Copenhagen, Denmark, 2730