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


Phase 4
20 Years
75 Years
Not Enrolling
Both
Sleep Initiation and Maintenance Disorders

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Patient Self-report Data on Sleep, Pain, and Fatigue

Outcome Time Frame:

2 days post treatment

Safety Issue:

No

Principal Investigator

Joel E Dimsdale, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UCSD

Authority:

United States: Institutional Review Board

Study ID:

UCSD 060340

NCT ID:

NCT00365261

Start Date:

September 2006

Completion Date:

December 2009

Related Keywords:

  • Sleep Initiation and Maintenance Disorders
  • pain
  • fatigue
  • sleep
  • bone marrow transplant
  • cancer
  • Sleep Initiation and Maintenance Disorders
  • Sleep Disorders
  • Dyssomnias
  • Parasomnias

Name

Location

UCSD Thornton HospitalLa Jolla, California  92037