Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer

NCT ID: NCT00365261

Last Updated: 2016-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-12-31

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.

Conditions

Sleep Initiation and Maintenance Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

eszopiclone

active drug

Group Type: ACTIVE_COMPARATOR

Eszopiclone

Intervention Type: DRUG

eszopiclone 2 to 3 mg po at bedtime

placebo

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo 2 to 3 mg po at bedtime

Interventions

Eszopiclone

eszopiclone 2 to 3 mg po at bedtime

Intervention Type: DRUG

Placebo

placebo 2 to 3 mg po at bedtime

Intervention Type: DRUG

Other Intervention Names

Lunesta

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Joel E. Dimsdale, M.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joel E Dimsdale, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

UCSD Thornton Hospital

La Jolla, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21116652 (View on PubMed)

Other Identifiers

ESRC 054

Identifier Type: OTHER

Identifier Source: secondary_id

UCSD 060340

Identifier Type: -

Identifier Source: org_study_id