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Sleep and Endometrial Cancer
This study is currently recruiting participants.
Verified by University of Pittsburgh, January 2010
First Received: July 8, 2009   Last Updated: January 12, 2010   History of Changes
Sponsor: University of Pittsburgh
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00936598
  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: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: July 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
zolpidem: Experimental 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.
sugar pill: Placebo Comparator 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.

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

Contacts
Contact: Sondra Swain, BSN, RN 412-641-7532 swainsh@upmc.edu
Contact: Jessica Manculich, BS 412-623-8942 manculichjf@upmc.edu

Locations
United States, Pennsylvania
UPMC Mercy Recruiting
Pittsburgh, Pennsylvania, United States, 15219
Magee-Womens Hospital of UPMC Recruiting
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: University of Pittsburgh ( Dana Howard Bovbjerg )
Study ID Numbers: PRO09040160, PCI-09-027
Study First Received: July 8, 2009
Last Updated: January 12, 2010
ClinicalTrials.gov Identifier: NCT00936598     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Sleep
Endometrial Neoplasms
Pain

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

ClinicalTrials.gov processed this record on February 08, 2010