Clinical trial · Observational
Circadian Disturbances After Breast Cancer Surgery
NCT01171508CI-TRIAL-00009678CIRCAcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Circadian Rhythm Disorders | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Holter monitor - Medilog AR12 (Oxford Instruments, Oxford, England) | Device | — | UNRESOLVED |
| Karolinska Sleepiness Scale | Other | — | UNRESOLVED |
| Polysomnograph - Embla A10 (Medcare, Reykjavik, Iceland) | Device | — | UNRESOLVED |
| Sleep-diary | Other | — | UNRESOLVED |
| Urine 6-sulphatoxymelatonin (aMT6s) | Procedure | — | UNRESOLVED |
| Visual Analog Scale and 10 point-scales to measure fatigue, general well-being, subjective sleep and pain | Other | — | UNRESOLVED |
| Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USA | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast cancer patients
- description
- 12 breast cancer patients aged 30-70 years undergoing a lumpectomy at Herlev Hospital. ASA score I-III.
- interventionNames
- 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
Primary outcomes (8)
- measure
- Preoperative sleep architecture of breast cancer patients
- timeFrame
- 1 day preoperatively
- description
- Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.