Sleep and Endometrial Cancer

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00936598
• Collaborator: (none)
• Enrollment: 6
• Locations: 2
• Arms: 2
• Duration (Months): 21
• Patients Per Site: 3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep; Endometrial Neoplasms; Pain	Drug: zolpidem; Drug: sugar pill	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Surgery for Endometrial Cancer: Biobehavioral Analysis of Sleep, Stress and Pain
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

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.	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 Names: 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 Names: placebo

Outcome Measures

Primary Outcome Measures

1. Brief Pain Inventory (Short-form) [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).

Secondary Outcome Measures

1. Pain Severity Visual Analogue Scale [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."

2. Daily Analgesic Medication Consumption (Morphine Equivalency) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania	United States	15213
2	UPMC Mercy	Pittsburgh	Pennsylvania	United States	15219

Sponsors and Collaborators

• University of Pittsburgh

Investigators

• Principal Investigator: Dana H Bovbjerg, PhD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dana Bovbjerg, Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT00936598
• Other Study ID Numbers: PRO09040160; PCI-09-027
• First Posted: Jul 10, 2009
• Last Update Posted: Apr 24, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Dana Bovbjerg, Professor, University of Pittsburgh: Sleep; Endometrial Neoplasms; Pain
• Additional relevant MeSH terms: Endometrial Neoplasms; Zolpidem

Study Results

Participant Flow

Recruitment Details	Recruitment occurred between January 2010 and May 2010 at Magee Womens Hospital and Mercy Hospital. All participants who were recruited were assigned to one arm or the other.
Pre-assignment Detail	One participant in the placebo group was found to be ineligible after consent before starting the study (before being provided with take home materials).

Arm/Group Title	Zolpidem	Sugar Pill
Arm/Group Description	Participants randomized to the 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) and 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.	Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and 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.
Period Title: Overall Study
STARTED	4	1
COMPLETED	2	1
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Zolpidem	Sugar Pill	Total
Arm/Group Description	Participants randomized to the 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) and 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.	Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and 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.	Total of all reporting groups
Overall Participants	4	1	5
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 75%	1 100%	4 80%
>=65 years	1 25%	0 0%	1 20%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53 (20.7)	60 (0)	54.4 (18.2)
Sex: Female, Male (Count of Participants)
Female	4 100%	1 100%	5 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	4 100%	1 100%	5 100%

Outcome Measures

1. Primary Outcome

Title	Brief Pain Inventory (Short-form)
Description	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).
Time Frame	at the clinical follow-up appointment approximately 7-10 days after surgery

Outcome Measure Data

Analysis Population Description

Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.

Arm/Group Title	Zolpidem	Sugar Pill
Arm/Group Description	Participants randomized to the 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) and 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.	Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and 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.
Measure Participants	0	0

2. Secondary Outcome

Title	Pain Severity Visual Analogue Scale
Description	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."
Time Frame	each of the days following surgery until the clinical follow-up appointment

Outcome Measure Data

Analysis Population Description

Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.

Arm/Group Title	Zolpidem	Sugar Pill
Arm/Group Description	Participants randomized to the 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) and 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.	Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and 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.
Measure Participants	0	0

3. Secondary Outcome

Title	Daily Analgesic Medication Consumption (Morphine Equivalency)
Description	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.
Time Frame	daily from the day of surgery until the clinical follow-up appointment

Outcome Measure Data

Analysis Population Description

Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.

Arm/Group Title	Zolpidem	Sugar Pill
Arm/Group Description	Participants randomized to the 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) and 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.	Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and 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.
Measure Participants	0	0

Adverse Events

Arm/Group Title	Zolpidem		Sugar Pill
Arm/Group Description	Participants randomized to the 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) and 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.		Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and 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.
All Cause Mortality
	Zolpidem		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Zolpidem		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Zolpidem		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.