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Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer
This study is currently recruiting participants.
Study NCT00365261   Information provided by University of California, San Diego
First Received: August 15, 2006   Last Updated: August 3, 2009   History of Changes

August 15, 2006
August 3, 2009
September 2006
December 2009   (final data collection date for primary outcome measure)
Patient Self-report data on sleep, pain, and fatigue
  • Patient Self-report data on
  • sleep,
  • pain,
  • fatigue
Complete list of historical versions of study NCT00365261 on ClinicalTrials.gov Archive Site
Opiate dosing from patient controlled analgesia
Same as current
 
Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer
Effect of Eszopiclone (Lunesta) on Sleep Disturbance and Pain in Cancer

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

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.

Phase IV
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Sleep Initiation and Maintenance Disorders
Drug: eszopiclone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
50
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Both
20 Years to 75 Years
No
 
United States
 
NCT00365261
 
UCSD 060340, ESRC 054
University of California, San Diego
 
Principal Investigator: Joel E Dimsdale, MD UCSD
University of California, San Diego
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP