NCT00365261

Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer

Effect of Eszopiclone (Lunesta) on Sleep Disturbance and Pain in Cancer

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Sleep Initiation and Maintenance Disorders

Interventions

Type	Name	Description
DRUG	Eszopiclone	eszopiclone 2 to 3 mg po at bedtime
DRUG	Placebo	placebo 2 to 3 mg po at bedtime

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2006-08-17
• Last updated: 2016-07-11
• Results posted: 2011-09-29

Locations

1 site across 1 country: United States