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Sleep and Endometrial Cancer

This study has been terminated.
(Investigator-initiated termination of approval due to problems with recruitment.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00936598
First Posted: July 10, 2009
Last Update Posted: April 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dana Bovbjerg, University of Pittsburgh
July 8, 2009
July 10, 2009
June 15, 2012
July 20, 2012
April 24, 2014
July 2009
April 2011   (Final data collection date for primary outcome measure)
Brief Pain Inventory (Short-form) [ Time Frame: at the clinical follow-up appointment approximately 7-10 days after surgery ]
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. Both subscales have a range of 0-10 with higher scores indicating worse outcomes (more intense pain and more pain interference).
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 ]
Complete list of historical versions of study NCT00936598 on ClinicalTrials.gov Archive Site
  • Pain Severity Visual Analogue Scale [ Time Frame: each of the days following surgery until the clinical follow-up appointment ]
    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). VAS pain severity yields a score of 0 to 100, with 100 indicating pain "as bad as it could be."
  • Daily Analgesic Medication Consumption (Morphine Equivalency) [ Time Frame: daily from the day of surgery until the clinical follow-up appointment ]
    Analgesic medication consumption will be calculated (morphine equivalent daily dose (MEDD)) on a daily basis using data down loaded from the patient-controlled analgesia (PCA) pump supplemented by information from clinical charts and patient self report on the daily diary form. MEDD starts at zero and does not have an upper limit; higher daily doses indicate more analgesic medication consumption, and thus more pain.
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Sleep and Endometrial Cancer
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Sleep
  • Endometrial Neoplasms
  • Pain
  • 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.
    Other Name: Ambien
  • 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.
    Other Name: placebo
  • Experimental: zolpidem
    Participants randomized to the zolpidem (intervention) group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute. During their presurgery visit (visit 1), participants will be provided with their capsule and instructed to take it by mouth immediately before bedtime the night before surgery.
    Intervention: Drug: zolpidem
  • Placebo Comparator: sugar pill
    Participants randomized to the sugar pill (control) group will receive placebo. For the purposes of this double-blind trial, placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute. During their presurgery visit (visit 1), participants will be provided with their capsule and instructed to take it by mouth immediately before bedtime the night before surgery.
    Intervention: Drug: sugar pill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
April 2011
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00936598
PRO09040160
PCI-09-027 ( Other Identifier: University of Pittsburgh Cancer Institute )
Yes
Not Provided
Not Provided
Dana Bovbjerg, University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Dana H Bovbjerg, PhD University of Pittsburgh
University of Pittsburgh
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP