Circadian Disturbances After Breast Cancer Surgery

NCT01171508 | Completed

• 1 other identifier: MVH-02
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Circadian Rhythm Disorders; Anxiety; Breast Cancer

Keywords

Circadian Rhythm Disorders; Breast Neoplasms Surgery; Sleep; Heart Rate

Outcome Measures

Primary Outcomes (8)

• Preoperative sleep architecture of breast cancer patients

  Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings).

  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)

  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)

  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.

  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.

  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.

  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.

  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.

  1 day preoperatively till 14 days postoperatively

Secondary Outcomes (3)

• Preoperative heart-rate variability of breast cancer patients

  1 day preoperatively

• Postoperative heart-rate variability of breast cancer patients (early phase)

  The first postoperative night

• Postoperative heart-rate variability of breast cancer patients (late phase)

  The 14th postoperative night

Study Arms (1)

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; 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

Interventions

Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USA DEVICE

Wrist-Actigraph to be worn on the non-dominant arm on day 0-3-17 of the study.

Breast cancer patients

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).

Breast cancer patients

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.

Breast cancer patients

Urine 6-sulphatoxymelatonin (aMT6s) PROCEDURE

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.

Breast cancer patients

Karolinska Sleepiness Scale OTHER

Karolinska Sleepiness Scale to measure sleepiness will be filled out twice a day every day of the entire study period of 17 days.

Breast cancer patients

Visual Analog Scale and 10 point-scales to measure fatigue, general well-being, subjective sleep and pain OTHER

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.

Breast cancer patients

Sleep-diary OTHER

Sleep-diary to measure subjective sleep quantity will be completed every morning and after every nap in the day.

Breast cancer patients

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Department of Breast Surgery at Herlev University Hospital in Copenhagen

You may qualify if:

• women, age 30-70, with breast cancer who are admitted for a lumpectomy at Herlev Hospital
• ASA score I-III

You may not qualify if:

• 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

Sponsors & Collaborators

• Melissa Voigt Hansen: lead

Study Sites (1)

Herlev Hospital

Copenhagen, 2730, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Chronobiology Disorders; Anxiety Disorders; Breast Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Diseases; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Melissa V Hansen, MD

  Herlev Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D. ph.D student

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: July 28, 2010
• Study Start: February 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 8, 2013

Record last verified: 2013-03

Locations

DK (1)