Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00365261
First received: August 15, 2006
Last updated: August 24, 2011
Last verified: June 2010
  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 4

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:


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:

  1. Male or female patients hospitalized for chemotherapy or blood/bone marrow transplant.
  2. Age 20 - 75
  3. Not currently regularly taking any prescribed sleeping pill more often than 4x/week.
  4. Can tolerate oral medication.

Exclusion Criteria:

  1. Patients with a current history of substance abuse
  2. Patients with a history of allergic response to Lunesta.
  3. Patient who require additional oral or parenteral opioids after starting PCA opioid treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 27, 2014