Circadian Disturbances After Breast Cancer Surgery

Brief Summary

Official Title: “Circadian Disturbances After Breast Cancer Surgery”

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.

  • Study Type: Observational
  • Study Design: Observational Model: Cohort, Time Perspective: Prospective
  • Study Primary Completion Date: November 2011

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • Device: Wrist-Actigraph – Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USA
    • Wrist-Actigraph to be worn on the non-dominant arm on day 0-3-17 of the study.
  • Device: 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: 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.
  • Procedure: 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.
  • Other: Karolinska Sleepiness Scale
    • Karolinska Sleepiness Scale to measure sleepiness will be filled out twice a day every day of the entire study period of 17 days.
  • Other: Visual Analog Scale and 10 point-scales to measure fatigue, general well-being, subjective sleep and pain
    • 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.
  • Other: Sleep-diary
    • Sleep-diary to measure subjective sleep quantity will be completed every morning and after every nap in the day.

Arms, Groups and Cohorts in this Clinical Trial

  • Breast cancer patients
    • 12 breast cancer patients aged 30-70 years undergoing a lumpectomy at Herlev Hospital. ASA score I-III.

Outcome Measures for this Clinical Trial

Primary Measures

  • Preoperative sleep architecture of breast cancer patients
    • Time Frame: 1 day preoperatively
      Safety Issue?: No
  • Postoperative sleep architecture of breast cancer patients (early phase)
    • Time Frame: The first postoperative night
      Safety Issue?: No
  • Postoperative sleep architecture of breast cancer patients (late phase)
    • Time Frame: The 14th postoperative night
      Safety Issue?: No
  • Sleep quality, fatigue, well-being and pain.
    • Time Frame: 1 day preoperatively till 14 days postoperatively
      Safety Issue?: No
  • Preoperative melatonin levels and amplitude
    • Time Frame: 1 day preoperatively
      Safety Issue?: No
  • Postoperative melatonin levels and amplitude (early phase)
    • Time Frame: The first postoperative night
      Safety Issue?: No
  • Postoperative melatonin levels and amplitude
    • Time Frame: The 14th postoperative night
      Safety Issue?: No
  • Sleep architecture
    • Time Frame: 1 day preoperatively till 14 days postoperatively
      Safety Issue?: No

Secondary Measures

  • Preoperative heart-rate variability of breast cancer patients
    • Time Frame: 1 day preoperatively
      Safety Issue?: No
  • Postoperative heart-rate variability of breast cancer patients (early phase)
    • Time Frame: The first postoperative night
      Safety Issue?: No
  • Postoperative heart-rate variability of breast cancer patients (late phase)
    • Time Frame: The 14th postoperative night
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Melissa Voigt Hansen
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Melissa Voigt Hansen, M.D. ph.D student – Herlev Hospital
  • Overall Official(s)
    • Melissa V Hansen, MD, Principal Investigator, Herlev Hospital

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01171508