Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519168
Status:
COMPLETED
Last Update Posted:
2017-10-06
First Post:
2007-08-20
Brief Title:
Sleep Circadian Hormonal Dysregulation and Breast Cancer Survival
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Sleep Circadian Hormonal Dysregulation and Breast Cancer Survival
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 women with metastatic or recurrent breast cancer Hypothesis 1 Women with metastatic or recurrent breast cancer will have reduced amplitude and disrupted phase of 24-hr diurnal rhythms of cortisol ACTH and melatonin Aim 2 To describe sleep disruption in women with metastatic breast cancer and examine psychosocial endocrine and immune factors that may be associated with sleep disruption Hypothesis 2 Women with metastatic or recurrent breast cancer will have a higher incidence of both at home and laboratory-examined sleep disruption than control women without breast cancer Hypothesis 3 Poorer sleep quality will be associated with more pain more emotional suppression in response to stressors less emotional support greater depression and anxiety and greater perceived and traumatic stress Hypothesis 4 Poorer sleep quality and quantity of sleep and daytime sleepiness and fatigue will be associated with abnormal circadian neuroendocrine ie cortisol ACTH and melatonin and immune patterns ie suppressed day and night time NK activity and loss of NK rhythms increased day time IL-6 levels and or loss of IL-6 rhythm Aim 3 To study the relationship between sleep disruption and survival time among metastatic and recurrent breast cancer patients Hypothesis 5 Poorer sleep quality and quantity of sleep will predict shorter survival Hypothesis 6 Reduced diurnal amplitude and an abnormal phase of cortisol will predict shorter survival Explanatory Aim 4 To investigate whether sleep disruption mediates the relation of psychosocial factors to health outcomes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BRSADJ0013 | OTHER | Stanford University | None |
| 97312 | OTHER | None | None |