Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer

Sleep Initiation and Maintenance Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00365261
• Other study ID #: UCSD 060340
• Secondary ID: ESRC 054
• Status: Completed
• Phase: Phase 4
• First received: August 15, 2006
• Last updated: December 16, 2015
• Start date: September 2006
• Est. completion date: December 2009

Study information

• Verified date: December 2015
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disorders
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Eszopiclone
eszopiclone 2 to 3 mg po at bedtime
• Placebo
placebo 2 to 3 mg po at bedtime

Locations

Country	Name	City	State
United States	UCSD Thornton Hospital	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Self-report Data on Sleep, Pain, and Fatigue		2 days post treatment	No
Primary	Pain	self report of pain (1=no pain; 10=worst imaginable pain	post dosing	No
Secondary	Opiate Dosing From Patient Controlled Analgesia		2 days post dosing	No