Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer
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|ClinicalTrials.gov Identifier: NCT00365261|
Recruitment Status : Completed
First Posted : August 17, 2006
Results First Posted : September 29, 2011
Last Update Posted : July 11, 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 or disease||Intervention/treatment||Phase|
|Sleep Initiation and Maintenance Disorders||Drug: Eszopiclone Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Eszopiclone (Lunesta) on Sleep Disturbance and Pain in Cancer|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
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 [ 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365261
|United States, California|
|UCSD Thornton Hospital|
|La Jolla, California, United States, 92037|
|Principal Investigator:||Joel E Dimsdale, MD||UCSD|