Clinical trial NCT01171508: Circadian Disturbances After Breast Cancer Surgery
Official title: Circadian Disturbances After Breast Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Circadian Rhythm Disorders
Anxiety
Breast Cancer
Keywords: Circadian Rhythm Disorders
Breast Neoplasms Surgery
Sleep
Heart Rate
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2010-07-28
Enrollment: 12
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Department of Breast Surgery at Herlev University Hospital in Copenhagen

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Preoperative sleep architecture of breast cancer patients
timeFrame: 1 day preoperatively
measure: Postoperative sleep architecture of breast cancer patients (early phase)
timeFrame: The first postoperative night
measure: Postoperative sleep architecture of breast cancer patients (late phase)
timeFrame: The 14th postoperative night
measure: Sleep quality, fatigue, well-being and pain.
timeFrame: 1 day preoperatively till 14 days postoperatively
measure: Preoperative melatonin levels and amplitude
timeFrame: 1 day preoperatively
measure: Postoperative melatonin levels and amplitude (early phase)
timeFrame: The first postoperative night
measure: Postoperative melatonin levels and amplitude
timeFrame: The 14th postoperative night
measure: Sleep architecture
timeFrame: 1 day preoperatively till 14 days postoperatively
Secondary outcomes:
measure: Preoperative heart-rate variability of breast cancer patients
timeFrame: 1 day preoperatively
measure: Postoperative heart-rate variability of breast cancer patients (early phase)
timeFrame: The first postoperative night
measure: Postoperative heart-rate variability of breast cancer patients (late phase)
timeFrame: The 14th postoperative night
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Herlev Hospital
name: Melissa V Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References: