Sleep and Endometrial Cancer

Official Title: “Surgery for Endometrial Cancer: Biobehavioral Analysis of Sleep, Stress and Pain”

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.

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.

Intervention(s) in this Clinical Trial

• Drug: zolpidem
  • Participants will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women = or > 65 years) during their presurgery visit and will be instructed to take the single capsule by mouth immediately before bedtime the night before surgery.
• Drug: sugar pill
  • Participants will receive placebo (sugar) pills during their presurgery visit and will be instructed to take the single capsule by mouth immediately before bedtime the night before surgery.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: zolpidem
• Placebo Comparator: sugar pill

Primary Measures

• 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.
  • Time Frame: at the clinical follow-up appointment approximately 7-10 days after surgery
    Safety Issue?: No

Secondary Measures

• 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).
  • Time Frame: each of the days following surgery until the clinical follow-up appointment
    Safety Issue?: No
• 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.
  • Time Frame: daily from the day of surgery until the clinical follow-up appointment
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Pittsburgh Other

Overall Clinical Trial Officials and Contacts

Dana H Bovbjerg, PhD Principal Investigator University of Pittsburgh  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00936598

Study ID Number: PRO09040160

ClinicalTrials.gov Identifier: NCT00936598

Health Authority: United States: Institutional Review Board