Endometrial Neoplasms, Pain, Sleep
Conditions
Keywords
Sleep, Endometrial Neoplasms, Pain
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.
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.
Interventions
DRUGzolpidem
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.
DRUGsugar 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.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
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 details
One participant in the placebo group was found to be ineligible after consent before starting the study (before being provided with take home materials).
Participants by arm
| Arm | Count |
|---|---|
| Zolpidem 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. | 4 |
| Sugar Pill 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. | 1 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Ineligible after consent | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Sugar Pill | Zolpidem | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 0 | 53 years STANDARD_DEVIATION 20.7 | 54.4 years STANDARD_DEVIATION 18.2 |
| Region of Enrollment United States | 1 participants | 4 participants | 5 participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 1 |
| serious Total, serious adverse events | 0 / 4 | 0 / 1 |
Outcome results
Primary
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).
Time frame: at the clinical follow-up appointment approximately 7-10 days after surgery
Population: Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.
Secondary
Daily Analgesic Medication Consumption (Morphine Equivalency)
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
Population: Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.
Secondary
Pain Severity Visual Analogue Scale
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
Population: Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.