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Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer

This study has been completed.
Information provided by (Responsible Party):
Joel E. Dimsdale, M.D., University of California, San Diego Identifier:
First received: August 15, 2006
Last updated: June 3, 2016
Last verified: June 2016

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 Intervention Phase
Sleep Initiation and Maintenance Disorders Drug: Eszopiclone Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Eszopiclone (Lunesta) on Sleep Disturbance and Pain in Cancer

Resource links provided by NLM:

Further study details as provided by Joel E. Dimsdale, M.D., University of California, San Diego:

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

  • 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:
  • 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.

Enrollment: 45
Study Start Date: September 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: eszopiclone
active drug
Drug: Eszopiclone
eszopiclone 2 to 3 mg po at bedtime
Other Name: Lunesta
Placebo Comparator: placebo
Drug: Placebo
placebo 2 to 3 mg po at bedtime

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.


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

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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Please refer to this study by its identifier: NCT00365261

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

Responsible Party: Joel E. Dimsdale, M.D., Professor, University of California, San Diego Identifier: NCT00365261     History of Changes
Other Study ID Numbers: UCSD 060340
ESRC 054 ( Other Identifier: Sepracor )
Study First Received: August 15, 2006
Results First Received: August 24, 2011
Last Updated: June 3, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Joel E. Dimsdale, M.D., University of California, San Diego:
bone marrow transplant

Additional relevant MeSH terms:
Sleep Wake Disorders
Sleep Initiation and Maintenance Disorders
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on June 23, 2017