Sleep and Endometrial Cancer
Information source: University of Pittsburgh
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sleep; Endometrial Neoplasms; Pain
Intervention: zolpidem (Drug); sugar pill (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s):
Dana H Bovbjerg, PhD, Principal Investigator, Affiliation: University of Pittsburgh
Overall contact:
Sondra Swain, BSN, RN, Phone: 412-641-7532, Email: swainsh@upmc.edu
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.
Clinical Details
Official title: Surgery for Endometrial Cancer: Biobehavioral Analysis of Sleep, Stress and Pain
Study design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Pain intensity and pain interference subscales from the Brief Pain Inventory
(Short-form) (BPI) will be used to measure pain over the interval following surgery.
Secondary outcome: Pain severity will be assessed daily following surgery with a visual
analogue scale (VAS) completed by participants each night before they go to bed (daily diary PM).Analgesic medication consumption will be calculated (morphine equivalency) on a daily basis using data down loaded from the PCA pump supplemented by information
from clinical charts and patient self report on the daily diary form.
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 considerable pain relief, but they have multiple adverse side effects and
are not entirely effective. For cancer patients, uncontrolled postoperative pain can have a
substantial negative effect on quality of life, can slow recovery, increase the likelihood
of complications, and contribute to poorer postoperative outcomes. The identification of
novel modifiable patient risk factors for post surgery pain that could become the target of
presurgery interventions is thus an important goal. We will conduct a randomized,
placebo-controlled, double-blind intervention trial design to evaluate the effects of an FDA
approved hypnotic (zolpidem) on post surgery pain. Since presurgery psychological factors
(e. g., heightened anxiety) are known to predict the severity of post surgical pain and may
be associated with poor sleep, we will also assess psychological factors (with
questionnaires) as well as sleep (using actigraphy) in order to determine their individual
and combined impact on women's experiences of post surgery pain in this stressful clinical
context. Aim 1: To determine the impact of zolpidem administered the night prior to
endometrial cancer surgery on women's experiences of pain over the initial 7-10 day
follow-up period after surgery using a double-blind placebo-controlled design (final n=128).
Aim 2: To investigate psychological factors on the morning before surgery, as well as
objective sleep variables on the night before surgery, as possible mediators of the
beneficial effects of zolpidem on post surgery pain. Aim 3: To examine psychological
factors, as well as sleep variables, assessed prior to the sleep intervention as possible
moderators of the ameliorative effects of zolpidem on post surgery pain. The results of the
proposed exploratory study would provide the preliminary data necessary for an R01
application to support more comprehensive investigations, including explorations of
biological mechanisms underlying the preventative effects of better presurgery sleep on
patients' experiences of post surgery pain.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
- are unable to complete study measures
- are unable to provide meaningful informed consent
Locations and Contacts
Sondra Swain, BSN, RN, Phone: 412-641-7532, Email: swainsh@upmc.edu
UPMC Mercy, Pittsburgh, Pennsylvania 15219, United States; Recruiting
Magee-Womens Hospital of UPMC, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Additional Information
Starting date: July 2009
Ending date: June 2011
Last updated: July 9, 2009
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