Circadian Disturbances After Breast Cancer Surgery
Klíčová slova
Abstraktní
Popis
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.
Termíny
| Poslední ověření: | 02/28/2013 |
| První předloženo: | 07/25/2010 |
| Odhadovaná registrace vložena: | 07/26/2010 |
| První zveřejnění: | 07/27/2010 |
| Poslední aktualizace byla odeslána: | 03/06/2013 |
| Poslední aktualizace zveřejněna: | 03/07/2013 |
| Aktuální datum zahájení studie: | 01/31/2011 |
| Odhadované datum dokončení primární: | 10/31/2011 |
| Odhadované datum dokončení studie: | 10/31/2011 |
Stav nebo nemoc
Intervence / léčba
Device: Breast cancer patients
Device: Breast cancer patients
Device: Breast cancer patients
Procedure: Breast cancer patients
Other: Breast cancer patients
Other: Breast cancer patients
Other: Breast cancer patients
Fáze
Skupiny zbraní
| Paže | Intervence / léčba |
|---|---|
| Breast cancer patients 12 breast cancer patients aged 30-70 years undergoing a lumpectomy at Herlev Hospital. ASA score I-III. | Device: Breast cancer patients Wrist-Actigraph to be worn on the non-dominant arm on day 0-3-17 of the study. |
Kritéria způsobilosti
| Věky způsobilé ke studiu | 30 Years Na 30 Years |
| Pohlaví způsobilá ke studiu | Female |
| Metoda vzorkování | Non-Probability Sample |
| Přijímá zdravé dobrovolníky | Ano |
| Kritéria | 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 |
Výsledek
Primární výsledná opatření
1. Preoperative sleep architecture of breast cancer patients [1 day preoperatively]
2. Postoperative sleep architecture of breast cancer patients (early phase) [The first postoperative night]
3. Postoperative sleep architecture of breast cancer patients (late phase) [The 14th postoperative night]
4. Sleep quality, fatigue, well-being and pain. [1 day preoperatively till 14 days postoperatively]
5. Preoperative melatonin levels and amplitude [1 day preoperatively]
6. Postoperative melatonin levels and amplitude (early phase) [The first postoperative night]
7. Postoperative melatonin levels and amplitude [The 14th postoperative night]
8. Sleep architecture [1 day preoperatively till 14 days postoperatively]
Měření sekundárních výsledků
1. Preoperative heart-rate variability of breast cancer patients [1 day preoperatively]
2. Postoperative heart-rate variability of breast cancer patients (early phase) [The first postoperative night]
3. Postoperative heart-rate variability of breast cancer patients (late phase) [The 14th postoperative night]
