Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00519168 · ClinicalTrials.gov registry record
Sleep, Circadian Hormonal Dysregulation, and Breast Cancer Survival
A clinical trial, sponsored by Stanford University.
- Completed
- Registry status
- 141
- Enrollment target
NCT00519168: Completed study, sponsored by Stanford University.
NCT00519168 is a clinical trial that has completed, run by Stanford University. The registered enrollment target is 141 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00519168 has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- 141 participants
- Enrollment target
Study Summary
Recent research provides evidence that disrupted circadian rhythms, including hormonal patterns and sleep, are associated with increased risk of breast cancer incidence and faster progression to mortality. We have observed that a loss of normal diurnal cortisol rhythm associated with more awakenings during the night predicts early mortality with metastatic breast cancer. Other recent studies have shown that nighttime shift work is associated with higher breast cancer incidence, and in a murine model disrupting circadian cortisol cycles produced a doubling of implanted tumor growth. There is also recent evidence that abnormal clock genes are associated with cancer. However, it is not clear whether sleep disruption per se affects breast cancer progression, or whether such an effect is mediated by hormonal and immune dysregulation of this prevalent and hormone-mediated cancer. We propose to study sleep disruption as a prognostic factor in the progression of metastatic breast cancer. We will also examine sleep patterns in association with disrupted circadian rhythms of cortisol, ACTH, and melatonin as well as measures of immune function known to be salient to breast cancer progression. These are natural killer cell cytoxicity and specific cytokine, IL-6. We plan to recruit 105 women 45 years through 75 years with metastatic or recurrent breast cancer and 20 age and SES-matched controls for a two-week at home sleep study with Actiwatch and two nights of in-home EEG monitoring, followed by 28 hours of continuous blood sampling and one night of EEG sleep monitoring in our lab at Stanford. This will provide a full examination of circadian hormones associated with sleep patterns. We will relate these assessments to the subsequent course of breast cancer progression. Results of this study will provide specific evidence regarding how improved sleep management may affect the course of breast cancer. Aim 1: To study 24-hr diurnal rhythms of HPA axis hormones and melatonin in wom
Interventions
- PROCEDURE phlebotomy
- PROCEDURE Urine sample
- DEVICE Electrode sleep recorder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2006-09 |
| Est. Completion | 2011-08-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00519168
The ClinicalTrials.gov registry entry for NCT00519168 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which phlebotomy is the first listed.
NCT00519168 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00519168 about?
NCT00519168 is a clinical study titled "Sleep, Circadian Hormonal Dysregulation, and Breast Cancer Survival". Recent research provides evidence that disrupted circadian rhythms, including hormonal patterns and sleep, are associated with increased risk of breast cancer incidence and faster progression to mortality. We have observed that a loss of normal diurnal cortisol rhythm associated with more awakenings...
What is the current status of trial NCT00519168?
This trial is currently completed. The enrollment target is 141 participants. The study started on 2006-09. Estimated completion is 2011-08-31.
What interventions are being tested in trial NCT00519168?
The interventions under investigation include: phlebotomy (PROCEDURE), Urine sample (PROCEDURE), Electrode sleep recorder (DEVICE).
Who is sponsoring clinical trial NCT00519168?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.