Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer

• Sponsor: University of California, San Diego (Other)
• Overall Status: Completed
• CT.gov ID: NCT00365261
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Sleep Initiation and Maintenance Disorders	Drug: Eszopiclone; Drug: Placebo	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Eszopiclone (Lunesta) on Sleep Disturbance and Pain in Cancer
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: eszopiclone active drug	Drug: Eszopiclone; eszopiclone 2 to 3 mg po at bedtime; Other Names: Lunesta
Placebo Comparator: placebo placebo	Drug: Placebo; placebo 2 to 3 mg po at bedtime

Outcome Measures

Primary Outcome Measures

1. Pain [post dosing]

   Pain was assessed with a 10-cm visual analog scale (0 = "no pain at all"; 10 = "severe, uncontrolled pain").

2. Patient Self-report Data on Fatigue [2 days post treatment]

   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).

Secondary Outcome Measures

1. Opiate Dosing From Patient Controlled Analgesia [2 days post dosing]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joel E. Dimsdale, M.D., Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT00365261
• Other Study ID Numbers: UCSD 060340; ESRC 054
• First Posted: Aug 17, 2006
• Last Update Posted: Jul 11, 2016
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Joel E. Dimsdale, M.D., Professor, University of California, San Diego: pain; fatigue; sleep; bone marrow transplant; cancer
• Additional relevant MeSH terms: Dyssomnias; Parasomnias; Sleep Initiation and Maintenance Disorders; Eszopiclone

Study Results

Participant Flow

Arm/Group Title	Eszopiclone	Placebo
Arm/Group Description	receipt of active drug	receipt of placebo
Period Title: Overall Study
STARTED	23	22
COMPLETED	20	19
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Eszopiclone	Placebo	Total
Arm/Group Description	receipt of active drug	receipt of placebo	Total of all reporting groups
Overall Participants	23	22	45
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	23 100%	20 90.9%	43 95.6%
>=65 years	0 0%	2 9.1%	2 4.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.52 (13.06)	46 (15.86)	45.76 (14.33)
Sex: Female, Male (Count of Participants)
Female	13 56.5%	9 40.9%	22 48.9%
Male	10 43.5%	13 59.1%	23 51.1%
Region of Enrollment (participants) [Number]
United States	23 100%	22 100%	45 100%

Outcome Measures

1. Primary Outcome

Title	Pain
Description	Pain was assessed with a 10-cm visual analog scale (0 = "no pain at all"; 10 = "severe, uncontrolled pain").
Time Frame	post dosing

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eszopiclone	Placebo
Arm/Group Description	active drug	placebo
Measure Participants	23	22
Mean (Standard Error) [scores on a scale]	3.72 (0.38)	5.41 (0.47)

2. Primary Outcome

Title	Patient Self-report Data on Fatigue
Description	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).
Time Frame	2 days post treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eszopiclone	Placebo
Arm/Group Description	active drug Eszopiclone: eszopiclone 2 to 3 mg po at bedtime	placebo Placebo: placebo 2 to 3 mg po at bedtime
Measure Participants	23	22
Mean (Standard Error) [scores on a scale]	2.41 (0.20)	2.77 (0.17)

3. Secondary Outcome

Title	Opiate Dosing From Patient Controlled Analgesia
Description	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.
Time Frame	2 days post dosing

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eszopiclone	Placebo
Arm/Group Description	active drug	placebo
Measure Participants	23	22
Median (Inter-Quartile Range) [mg]	36.35	40.94

Adverse Events

Arm/Group Title	Eszopiclone		Placebo
Arm/Group Description	receipt of active drug		receipt of placebo
All Cause Mortality
	Eszopiclone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Eszopiclone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Eszopiclone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/23 (13%)		3/22 (13.6%)
General disorders
fatigue	3/23 (13%)	3	3/22 (13.6%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.