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Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00365261
Recruitment Status : Completed
First Posted : August 17, 2006
Results First Posted : September 29, 2011
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Joel E. Dimsdale, M.D., University of California, San Diego

Study Description
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Brief Summary:

To assess the effectiveness of Lunesta on cancer patients who have received chemotherapy and who require patient controlled analgesia (PCA), specifically to assess whether Lunesta will:

  • improve sleep thereby decreasing need for opiates via PCA
  • improve sleep thereby decreasing pain by self report
  • improve sleep thereby decreasing fatigue by self report

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Drug: Eszopiclone Drug: Placebo Phase 4

Detailed Description:

Pain and fatigue are the most common symptom complaints of cancer patients. Although dramatic improvements have come about in recognizing and treating cancer related pain, less progress has been made in treating fatigue. Interventions to improve sleep may offer benefit in terms of pain and fatigue.

One of the less commonly recognized side effects of opiate use is sleep disruption.

Experimentally-induced sleep disruption lowers the threshold for detection of painful stimuli. Thus, although opiates are obviously helpful for pain, they do so at certain "costs": they increase next day fatigue, constipation, and have other side effects; they disrupt sleep which further increases next day fatigue; and finally, by virtue of their sleep disruptive properties, they lower the threshold for pain stimuli.

Cancer patients requiring chemotherapy commonly require PCA because of oral mucositis. The objective of this study is to assess whether opiate usage may be reduced and complaints of fatigue and pain be lessened if patients had better sleep.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Eszopiclone (Lunesta) on Sleep Disturbance and Pain in Cancer
Study Start Date : September 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Eszopiclone

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: eszopiclone
active drug
 Drug: Eszopiclone
eszopiclone 2 to 3 mg po at bedtime
Other Name: Lunesta
Placebo Comparator: placebo
placebo
 Drug: Placebo
placebo 2 to 3 mg po at bedtime


Outcome Measures
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Primary Outcome Measures :
  1. Pain [ Time Frame: post dosing ]
    Pain was assessed with a 10-cm visual analog scale (0 = "no pain at all"; 10 = "severe, uncontrolled pain").

  2. Patient Self-report Data on Fatigue [ Time Frame: 2 days post treatment ]
    Patients completed the five-item Profile of Mood States Scale, Short Form (POMS-SF) Fatigue-Inertia Scale to rate their fatigue complaints (scores range from 0 to 28; higher scores denote more fatigue).


Secondary Outcome Measures :
  1. Opiate Dosing From Patient Controlled Analgesia [ Time Frame: 2 days post dosing ]
    Morphine or dilaudid dose delivered at fixed rate with optional self-administered prn boluses. Dilaudid doses were converted into morphine equivalents by multiplying the dose by 5.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients hospitalized for chemotherapy or blood/bone marrow transplant.
  2. Age 20 - 75
  3. Not currently regularly taking any prescribed sleeping pill more often than 4x/week.
  4. Can tolerate oral medication.

Exclusion Criteria:

  1. Patients with a current history of substance abuse
  2. Patients with a history of allergic response to Lunesta.
  3. Patient who require additional oral or parenteral opioids after starting PCA opioid treatment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365261


Locations
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United States, California
UCSD Thornton Hospital
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Joel E Dimsdale, MD UCSD
More Information
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Publications of Results:

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Responsible Party: Joel E. Dimsdale, M.D., Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00365261    
Other Study ID Numbers: UCSD 060340
ESRC 054 ( Other Identifier: Sepracor )
First Posted: August 17, 2006    Key Record Dates
Results First Posted: September 29, 2011
Last Update Posted: July 11, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Joel E. Dimsdale, M.D., University of California, San Diego:
pain
fatigue
sleep
bone marrow transplant
cancer
Additional relevant MeSH terms:
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Dyssomnias
Parasomnias
Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
 Sleep Disorders, Intrinsic
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs