Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer

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

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

Study Overview

• Status: Completed
• Conditions: Sleep Initiation and Maintenance Disorders
• Intervention / Treatment: Drug: Eszopiclone; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo	Drug: Placebo; placebo 2 to 3 mg po at bedtime
ACTIVE_COMPARATOR: eszopiclone; active drug	Drug: Eszopiclone; eszopiclone 2 to 3 mg po at bedtime; Other Names: Lunesta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain was assessed with a 10-cm visual analog scale (0 = "no pain at all"; 10 = "severe, uncontrolled pain").	post dosing
Patient Self-report Data on Fatigue	Patients completed the five-item Profile of Mood States Scale, Short Form (POMS-SF) Fatigue-Inertia Scale to rate their fatigue complaints (scores range from 0 to 28; higher scores denote more fatigue).	2 days post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opiate Dosing From Patient Controlled Analgesia	Morphine or dilaudid dose delivered at fixed rate with optional self-administered prn boluses. Dilaudid doses were converted into morphine equivalents by multiplying the dose by 5.	2 days post dosing

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Joel E Dimsdale, MD, UCSD

Publications and helpful links

General 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. 2011 Dec;19(12):2015-20. doi: 10.1007/s00520-010-1052-1. Epub 2010 Nov 30.

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: August 15, 2006
• First Submitted That Met QC Criteria: August 15, 2006
• First Posted (ESTIMATE): August 17, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): July 11, 2016
• Last Update Submitted That Met QC Criteria: June 3, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: pain; fatigue; sleep; cancer; bone marrow transplant
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Dyssomnias; Parasomnias; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives; Eszopiclone
• Other Study ID Numbers: UCSD 060340; ESRC 054 (OTHER: Sepracor)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO