Sleep and Endometrial Cancer

This study has been terminated.
(Investigator-initiated termination of approval due to problems with recruitment.)
Sponsor:
Information provided by (Responsible Party):
Dana Bovbjerg, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00936598
First received: July 8, 2009
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Sleep
Endometrial Neoplasms
Pain
Drug: zolpidem
Drug: sugar pill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Surgery for Endometrial Cancer: Biobehavioral Analysis of Sleep, Stress and Pain

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Brief Pain Inventory (Short-form) [ Time Frame: at the clinical follow-up appointment approximately 7-10 days after surgery ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Pain Severity Visual Analogue Scale [ Time Frame: each of the days following surgery until the clinical follow-up appointment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 6
Study Start Date: July 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936598

Locations
United States, Pennsylvania
UPMC Mercy
Pittsburgh, Pennsylvania, United States, 15219
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Dana H Bovbjerg, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Dana Bovbjerg, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00936598     History of Changes
Other Study ID Numbers: PRO09040160, PCI-09-027
Study First Received: July 8, 2009
Results First Received: June 15, 2012
Last Updated: April 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Sleep
Endometrial Neoplasms
Pain

Additional relevant MeSH terms:
Neoplasms
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014