Effect of Eszopiclone on Sleep Disturbance & Pain in Cancer

Condition(s) targeted: Sleep Initiation and Maintenance Disorders

Intervention: eszopiclone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of California, San Diego

Official(s) and/or principal investigator(s):
Joel E Dimsdale, MD, Principal Investigator, Affiliation: UCSD

To assess the effectiveness of Lunesta on cancer patients who have received a blood or marrow transplant 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

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

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

Patient Self-report data on

sleep,

pain,

fatigue

Secondary outcome: opiate dosing from patient controlled analgesia

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 blood/bone marrow transplants (BMT) 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.

Minimum age: 20 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Male or female patients hospitalized for 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.

UCSD Thornton Hospital, La Jolla, California 92037, United States; Recruiting
Joel E Dimsdale, MD, Phone: 619-543-5592, Email: jdimsdale@ucsd.edu
Joel E Dimsdale, MD, Principal Investigator

Starting date: September 2006
Ending date: March 2008
Last updated: February 14, 2007