Overview

Sleep and Endometrial Cancer

Status:
Terminated
Trial end date:
2011-04-01
Target enrollment:
0
Participant gender:
Female
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 need for analgesic medication.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Pittsburgh
Treatments:
Zolpidem
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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