Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer - Full Text View

Sponsor:	University of California, San Diego
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00365261

Purpose

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	Intervention	Phase
Sleep Initiation and Maintenance Disorders	Drug: Eszopiclone Drug: Placebo	Phase IV

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fatigue Sleep Disorders

Drug Information available for: Eszopiclone

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:

Patient Self-report Data on Sleep, Pain, and Fatigue [ Time Frame: 2 days post treatment ] [ Designated as safety issue: No ]
Pain [ Time Frame: post dosing ] [ Designated as safety issue: No ]
self report of pain (1=no pain; 10=worst imaginable pain

Secondary Outcome Measures:

Opiate Dosing From Patient Controlled Analgesia [ Time Frame: 2 days post dosing ] [ Designated as safety issue: No ]

Enrollment:	45
Study Start Date:	September 2006
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: eszopiclone active drug	Drug: Eszopiclone eszopiclone 2 to 3 mg po at bedtime
Placebo Comparator: placebo placebo	Drug: Placebo placebo 2 to 3 mg po at bedtime

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.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365261

Locations

United States, California
UCSD Thornton Hospital
La Jolla, California, United States, 92037

Sponsors and Collaborators

University of California, San Diego

Investigators

Principal Investigator:

Joel E Dimsdale, MD

UCSD

More Information

Publications:

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. 2010 Nov 30; [Epub ahead of print]

Responsible Party:	Joel E. Dimsdale, M.D., Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00365261 History of Changes
Other Study ID Numbers:	UCSD 060340, ESRC 054
Study First Received:	August 15, 2006
Results First Received:	August 24, 2011
Last Updated:	August 24, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Diego:

pain
fatigue
sleep
bone marrow transplant
cancer

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Sleep Disorders
Dyssomnias
Parasomnias
Sleep Disorders, Intrinsic
Nervous System Diseases
Mental Disorders
Neurologic Manifestations

Signs and Symptoms
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012