Status:
TERMINATED
Sleep and Endometrial Cancer
Lead Sponsor:
University of Pittsburgh
Conditions:
Sleep
Endometrial Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study proposes to test the hypothesis that zolpidem taken the night before major surgery for endometrial cancer will improve sleep efficiency and reduce post surgery pain, as well as reduce the n...
Detailed Description
Despite continuing improvements in surgical procedures and ancillary care, post surgery pain continues to be a nearly universal patient experience following major operative procedures. Opioids provide...
Eligibility Criteria
Inclusion
- be women at least 18 years old
- have clinical indications of primary endometrioid adenocarcinoma of the endometrium
- be scheduled for staging surgery by laparotomy under standardized protocols
- have the ability to communicate in English sufficient for completion of study materials
- have no neuromuscular/ movement disorders (for actigraphy purposes)
- have no uncontrolled medical, sleep, endocrine or psychiatric illness (as determined by their attending physician as part of clinical care)
- have no ongoing use of medication known to affect sleep or wake function (e.g., hypnotics, benzodiazepines, antidepressants, anxiolytics, antipsychotics, decongestants, sedating antihistamines, beta blockers, corticosteroids)
Exclusion
- have a history of previous or concomitant cancer
- have an estimated life expectancy of \< 6 months
- will be admitted to the hospital prior to the day of surgery
- are unable to complete study measures
- are unable to provide meaningful informed consent
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00936598
Start Date
July 1 2009
End Date
April 1 2011
Last Update
April 24 2014
Active Locations (2)
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1
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
2
UPMC Mercy
Pittsburgh, Pennsylvania, United States, 15219