UCSD Thornton Hospital
La Jolla, California, 92037, United States
NCT Number: NCT00365261
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
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Notify Me20 year–75 year
All sexes
Interventional
Phase 4
La Jolla, California, 92037, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
eszopiclone 2 to 3 mg po at bedtime
Other names: Lunesta
placebo 2 to 3 mg po at bedtime
Time frame: post dosing
Pain was assessed with a 10-cm visual analog scale (0 = "no pain at all"; 10 = "severe, uncontrolled pain").
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).
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.
University of California, San Diego
Other
Effect of Eszopiclone (Lunesta) on Sleep Disturbance and Pain in Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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