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Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer

Primary Purpose

Sleep Initiation and Maintenance Disorders

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Eszopiclone
Placebo
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring pain, fatigue, sleep, bone marrow transplant, cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSD Thornton Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

eszopiclone

placebo

Arm Description

active drug

placebo

Outcomes

Primary Outcome Measures

Pain
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
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).

Secondary Outcome Measures

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.

Full Information

First Posted
August 15, 2006
Last Updated
June 3, 2016
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT00365261
Brief Title
Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer
Official Title
Effect of Eszopiclone (Lunesta) on Sleep Disturbance and Pain in Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders
Keywords
pain, fatigue, sleep, bone marrow transplant, cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eszopiclone
Arm Type
Active Comparator
Arm Description
active drug
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Eszopiclone
Other Intervention Name(s)
Lunesta
Intervention Description
eszopiclone 2 to 3 mg po at bedtime
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo 2 to 3 mg po at bedtime
Primary Outcome Measure Information:
Title
Pain
Description
Pain was assessed with a 10-cm visual analog scale (0 = "no pain at all"; 10 = "severe, uncontrolled pain").
Time Frame
post dosing
Title
Patient Self-report Data on Fatigue
Description
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 treatment
Secondary Outcome Measure Information:
Title
Opiate Dosing From Patient Controlled Analgesia
Description
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.
Time Frame
2 days post dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel E Dimsdale, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Thornton Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21116652
Citation
Dimsdale JE, Ball ED, Carrier E, Wallace M, Holman P, Mulroney C, Shaikh F, Natarajan L. Effect of eszopiclone on sleep, fatigue, and pain in patients with mucositis associated with hematologic malignancies. Support Care Cancer. 2011 Dec;19(12):2015-20. doi: 10.1007/s00520-010-1052-1. Epub 2010 Nov 30.
Results Reference
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Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer

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