Clinical trial NCT00936598: Sleep and Endometrial Cancer
Official title: Surgery for Endometrial Cancer: Biobehavioral Analysis of Sleep, Stress and Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep
Endometrial Neoplasms
Pain
Keywords: Sleep
Endometrial Neoplasms
Pain
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2009-07-10
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 need for analgesic medication.

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 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

Primary outcomes:
measure: Brief Pain Inventory (Short-form)
timeFrame: at the clinical follow-up appointment approximately 7-10 days after surgery
Secondary outcomes:
measure: Pain Severity Visual Analogue Scale
timeFrame: each of the days following surgery until the clinical follow-up appointment
measure: Daily Analgesic Medication Consumption (Morphine Equivalency)
timeFrame: daily from the day of surgery until the clinical follow-up appointment
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Mercy
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Dana H Bovbjerg, PhD
role: PRINCIPAL_INVESTIGATOR
References: