Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Drug: Eszopiclone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients hospitalized for chemotherapy or blood/bone marrow transplant. Age 20 - 75 Not currently regularly taking any prescribed sleeping pill more often than 4x/week. Can tolerate oral medication. Exclusion Criteria: Patients with a current history of substance abuse Patients with a history of allergic response to Lunesta. Patient who require additional oral or parenteral opioids after starting PCA opioid treatment.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: eszopiclone<br>active drug | Drug: Eszopiclone<br>* eszopiclone 2 to 3 mg po at bedtime<br>* Other names: Lunesta;|
| Placebo Comparator: placebo<br>placebo | Drug: Placebo<br>* placebo 2 to 3 mg po at bedtime<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain was assessed with a 10-cm visual analog scale (0 = no pain at all; 10 = severe, uncontrolled pain). | post dosing | 
| Patient Self-report Data on Fatigue | 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). | 2 days post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiate Dosing From Patient Controlled Analgesia | 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. | 2 days post dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, fatigue, sleep, bone marrow transplant, cancer