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Sleep and Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT00936598
Recruitment Status : Terminated (Investigator-initiated termination of approval due to problems with recruitment.)
First Posted : July 10, 2009
Results First Posted : July 20, 2012
Last Update Posted : April 24, 2014
Sponsor:
Information provided by (Responsible Party):
Dana Bovbjerg, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE July 8, 2009
First Posted Date  ICMJE July 10, 2009
Results First Submitted Date  ICMJE June 15, 2012
Results First Posted Date  ICMJE July 20, 2012
Last Update Posted Date April 24, 2014
Study Start Date  ICMJE July 2009
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2014)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 9, 2009)
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 ]
Change History Complete list of historical versions of study NCT00936598 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2009)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep and Endometrial Cancer
Official Title  ICMJE Surgery for Endometrial Cancer: Biobehavioral Analysis of Sleep, Stress and Pain
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Sleep
  • Endometrial Neoplasms
  • Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 10, 2012)
6
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2009)
144
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00936598
Other Study ID Numbers  ICMJE PRO09040160
PCI-09-027 ( Other Identifier: University of Pittsburgh Cancer Institute )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dana Bovbjerg, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dana H Bovbjerg, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date April 2014

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