- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00936598
Sleep and Endometrial Cancer
April 4, 2014 updated by: Dana Bovbjerg, University of Pittsburgh
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Magee-Womens Hospital of UPMC
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Pittsburgh, Pennsylvania, United States, 15219
- UPMC Mercy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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 Names:
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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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Pain Inventory (Short-form)
Time Frame: at the clinical follow-up appointment approximately 7-10 days after surgery
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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).
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at the clinical follow-up appointment approximately 7-10 days after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Severity Visual Analogue Scale
Time Frame: each of the days following surgery until the clinical follow-up appointment
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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."
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each of the days following surgery until the clinical follow-up appointment
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Daily Analgesic Medication Consumption (Morphine Equivalency)
Time Frame: daily from the day of surgery until the clinical follow-up appointment
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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.
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daily from the day of surgery until the clinical follow-up appointment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dana H Bovbjerg, PhD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
July 8, 2009
First Submitted That Met QC Criteria
July 9, 2009
First Posted (Estimate)
July 10, 2009
Study Record Updates
Last Update Posted (Estimate)
April 24, 2014
Last Update Submitted That Met QC Criteria
April 4, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Endometrial Neoplasms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Hypnotics and Sedatives
- GABA Agents
- Sleep Aids, Pharmaceutical
- GABA-A Receptor Agonists
- GABA Agonists
- Zolpidem
Other Study ID Numbers
- PRO09040160
- PCI-09-027 (Other Identifier: University of Pittsburgh Cancer Institute)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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