Clinical Trial: Circadian Disturbances After Breast Cancer Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Circadian Disturbances After Breast Cancer Surgery

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 Summary:

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.


Sponsor: Melissa Voigt Hansen

Current Primary Outcome:

  • Preoperative sleep architecture of breast cancer patients [ Time Frame: 1 day preoperatively ]
    Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings).
  • Postoperative sleep architecture of breast cancer patients (early phase) [ Time Frame: The first postoperative night ]
    Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings)
  • Postoperative sleep architecture of breast cancer patients (late phase) [ Time Frame: The 14th postoperative night ]
    Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings)
  • Sleep quality, fatigue, well-being and pain. [ Time Frame: 1 day preoperatively till 14 days postoperatively ]
    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.
  • Preoperative melatonin levels and amplitude [ Time Frame: 1 day preoperatively ]
    Excretion of aMT6s in urine. Urine will be collected from 23-07, quantified and 2 samples will be taken to measure aMT6s.
  • Postoperative melatonin levels and amplitude (early phase) [ Time Frame: The first postoperative night ]
    Excretion of aMT6s in urine. Urin

    Original Primary Outcome:

    • Preoperative sleep quality and sleep architecture of breast cancer patients [ Time Frame: 1 day preoperatively ]

      Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings) and Actigraphy (total minutes asleep, sleep effectiveness, sleep latency, awakenings).

      Fatigue, generel well-being, subjective sleep and pain scores on a Visual Analog Scale or a 10 point-scale. Sleepiness measured by Karolinska Sleepiness Scale. A sleep-diary recording sleep quantity of day and night sleep.

    • Postoperative sleep quality and sleep architecture of breast cancer patients (early phase) [ Time Frame: The first postoperative day/night ]

      Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings) and Actigraphy (total minutes asleep, sleep effectiveness, sleep latency, awakenings).

      Fatigue, generel well-being, subjective sleep and pain scores on a Visual Analog Scale or a 10 point-scale. Sleepiness measured by Karolinska Sleepiness Scale. A sleep-diary recording sleep quantity of day and night sleep.

    • Postoperative sleep quality and sleep architecture of breast cancer patients (late phase) [ Time Frame: The 14th postoperative day/night ]

      Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings) and Actigraphy (total minutes asleep, sleep effectiveness, sleep latency,

      Current Secondary Outcome:

      • Preoperative heart-rate variability of breast cancer patients [ Time Frame: 1 day preoperatively ]
        Heart-rate variability measured by Holter monitor and a following analysis of frequency domain parameters.
      • Postoperative heart-rate variability of breast cancer patients (early phase) [ Time Frame: The first postoperative night ]
        Heart-rate variability measured by Holter monitor and a following analysis of frequency domain parameters.
      • Postoperative heart-rate variability of breast cancer patients (late phase) [ Time Frame: The 14th postoperative night ]
        Heart-rate variability measured by Holter monitor and a following analysis of frequency domain parameters.


      Original Secondary Outcome:

      • Preoperative heart-rate variability of breast cancer patients [ Time Frame: 1 day preoperatively ]
        Heart-rate variability measured by Holter monitor and a following analysis of frequency domain parameters.
      • Postoperative heart-rate variability of breast cancer patients (early phase) [ Time Frame: The first postoperative day/night ]
        Heart-rate variability measured by Holter monitor and a following analysis of frequency domain parameters.
      • Postoperative heart-rate variability of breast cancer patients (late phase) [ Time Frame: The 14th postoperative day/night ]
        Heart-rate variability measured by Holter monitor and a following analysis of frequency domain parameters.
      • Preoperative anxiety levels of breast cancer patients [ Time Frame: 1 day preoperatively ]
        Symptoms CheckList 92 Anxiety Scale to rate anxiety levels.
      • Postoperative anxiety levels of breast cancer patients (early phase) [ Time Frame: The first postoperative day ]
        Symptoms CheckList 92 Anxiety Scale to rate anxiety levels.
      • Postoperative anxiety levels of breast cancer patients (late phase) [ Time Frame: The 14th postoperative day ]
        Symptoms CheckList 92 Anxiety Scale to rate anxiety levels.


      Information By: Herlev Hospital

      Dates:
      Date Received: July 26, 2010
      Date Started: February 2011
      Date Completion:
      Last Updated: March 7, 2013
      Last Verified: March 2013