Sleep and Endometrial Cancer

NCT00936598 | Terminated Results DMC

• 2 other identifiers: PRO09040160PCI-09-027
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Sleep; Endometrial Neoplasms; Pain

Keywords

Sleep; Endometrial Neoplasms; Pain

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory (Short-form)

  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).

  at the clinical follow-up appointment approximately 7-10 days after surgery

Secondary Outcomes (2)

• Pain Severity Visual Analogue Scale

  each of the days following surgery until the clinical follow-up appointment

• Daily Analgesic Medication Consumption (Morphine Equivalency)

  daily from the day of surgery until the clinical follow-up appointment

Study Arms (2)

zolpidem

EXPERIMENTAL

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

sugar pill

PLACEBO COMPARATOR

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

Interventions

zolpidem DRUG

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.

Also known as: Ambien

zolpidem

sugar pill DRUG

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.

Also known as: placebo

sugar pill

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (2)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Mercy

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Pain

Interventions

Zolpidem; Sugars

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Professor
• Organization: University of Pittsburgh

bovbjergdh@upmc.edu

412-623-5965

Study Officials

• Dana H Bovbjerg, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 10, 2009
• Study Start: July 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 24, 2014
• Results First Posted: July 20, 2012

Record last verified: 2014-04

Locations

US (2)