Effect of Eszopiclone 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
Sleep Initiation and Maintenance Disorders
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Effect of Eszopiclone (Lunesta) on Sleep Disturbance and Pain in Cancer|
- Pain [ Time Frame: post dosing ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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).
- Opiate Dosing From Patient Controlled Analgesia [ Time Frame: 2 days post dosing ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2006|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Active Comparator: eszopiclone
eszopiclone 2 to 3 mg po at bedtime
Other Name: Lunesta
Placebo Comparator: placebo
placebo 2 to 3 mg po at bedtime
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365261
|United States, California|
|UCSD Thornton Hospital|
|La Jolla, California, United States, 92037|
|Principal Investigator:||Joel E Dimsdale, MD||UCSD|