Clinical trial NCT00365261: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: pain
fatigue
sleep
bone marrow transplant
cancer
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2006-08-17
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Pain
timeFrame: post dosing
measure: Patient Self-report Data on Fatigue
timeFrame: 2 days post treatment
Secondary outcomes:
measure: Opiate Dosing From Patient Controlled Analgesia
timeFrame: 2 days post dosing
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Thornton Hospital
state: California
Study officials:
affiliation: UCSD
name: Joel E Dimsdale, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.